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The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - | Placebo Comparator | fluoride toothpaste (Ultrabrite) |
|
| B - Postive control | Active Comparator | fluoride/triclosan/copolymer toothpaste |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride | Drug | Brush twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mombelli Plaque Index (mPI) for Natural Teeth | Modified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. | 3 months |
| Mombelli Plaque Index (mPI) for Natural Teeth | Modified Plaque Index (mPI) is a Dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. | 6 months |
| Mombelli Plaque Index (mPI) for Dental Implants | Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. | 3 months |
| Mombelli Plaque Index (mPI) for Dental Implants | Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. | 6 months |
| Löe-Silness Gingival Index Score (GI) - Natural Teeth | Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Mann, MSc | Principal Investigator | |
| Joseph J Zambon, DDS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of New York at Buffalo | Buffalo | New York | 14260-1604 | United States | ||
| The Hebrew University-Hadassah |
subjects were screened for medical and oral health criteria and given the assigned study treatment to brush with for the next 6 months. Enrolled subjects all had 1 dental implant and 1 natural tooth identified and used for clinical data information.
subjects were recruited by the PI at the clinical site
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| ID | Title | Description |
|---|---|---|
| FG000 | A - Fluoride Control | Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment. |
| FG001 | B - Postive Control | fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A - Fluoride Control | Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment. |
| BG001 | B - Postive Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mombelli Plaque Index (mPI) for Natural Teeth | Modified Plaque Index (mPI)is a Dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A - Fluoride Control | Fluoride toothpaste (Ultrabrite)group contained both 1 natural tooth site and 1 dental implant site for clinical assessment. |
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William De Vizio | Colgate Palmolive Co. | 732-878-7901 | William_Devizio@colpal.com |
Not provided
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D014260 | Triclosan |
| C546060 | hydrated silica gel-based toothpaste |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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| Triclosan, fluoride | Drug | Brush twice daily |
|
|
| 3 months |
| Löe-Silness Gingival Index Score (GI) - Natural Teeth | Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding.Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded. | 6 months |
| Löe-Silness Gingival Index Score (GI)- Dental Implants | Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded. | 3 months |
| Löe-Silness Gingival Index Score (GI)- Dental Implants | Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded. | 6 months |
| Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth | Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema. | 3 months |
| Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth | Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema;3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing,change in color, obvious oedema;5 = bleeding on probing, spontaneous bleeding,change in color,marked oedema. | 6 months |
| Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants | Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. | 3 months |
| Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants | Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. | 6 months |
| A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM). | 3 months |
| A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM). | 6 months |
| A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM). | 3 months |
| A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM). | 6 months |
| C.Rectus (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | 3 months |
| C.Rectus (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | 6 months |
| C.Rectus (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | 3 months |
| C.Rectus (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | 6 months |
| Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | 3 months |
| Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | 6 months |
| Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | 3 months |
| Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | 6 months |
| E.Corrodens (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM). | 3 months |
| E.Corrodens (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM). | 6 months |
| E.Corrodens (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM). | 3 months |
| E.Corrodens (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM). | 6 months |
| E.Saburreum (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| E.Saburreum (DNA Probe Analysis)- Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM). | 6 months |
| E.Saburreum (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| E.Saburreum (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 6 months |
| F.Nucleatum (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| F.Nucleatum (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM) | 6 months |
| F.Nucleatum (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| F.Nucleatum (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM). | 6 months |
| Neissera sp. (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| Neissera sp. (DNA Probe Analysis) Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | 6 months |
| Neissera sp. (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| Neissera sp. (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 6 months |
| P.Gingivalis (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM) | 3 months |
| P.Gingivalis (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM) | 6 months |
| P.Gingivalis (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM) | 3 months |
| P.Gingivalis (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM) | 6 months |
| P.Intermedia (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| P.Intermedia (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 6 months |
| P.Intermedia (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| P.Intermedia (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 6 months |
| P.Melaninogenica (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| P.Melaninogenica (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 6 months |
| P.Melaninogenica (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| P.Melaninogenica (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 6 months |
| Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM). | 6 months |
| Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 6 months |
| Streptococci (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM). | 3 months |
| Streptococci (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 6 months |
| Streptococci (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM). | 3 months |
| Streptococci (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM). | 6 months |
| T.Forsythia (DNA Probe Analysis)- Natural Teeth | 14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| T.Forsythia (DNA Probe Analysis)-Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 6 months |
| T.Forsythia (DNA Probe Analysis)- Dental Implants | 14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 3 months |
| T.Forsythia (DNA Probe Analysis)- Dental Implants | 14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | 6 months |
| Veillonella sp.(DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM) | 3 months |
| Veillonella sp.(DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM). | 6 months |
| Veillonella sp.(DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM) | 3 months |
| Veillonella sp.(DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM) | 6 months |
| Jerusalem |
| Israel |
fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Mombelli Plaque Index (mPI) for Natural Teeth | Modified Plaque Index (mPI) is a Dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Primary | Mombelli Plaque Index (mPI) for Dental Implants | Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Primary | Mombelli Plaque Index (mPI) for Dental Implants | Modified Plaque Index (mPI) is a dental plaque scale as follows 0 = No plaque, 1 = Separate flecks of plaque at the cervical margin;2 = Plaque can be seen by naked eye.3 = Abundance of soft matter. The lower the number the less plaque is present on the tooth. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Primary | Löe-Silness Gingival Index Score (GI) - Natural Teeth | Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Primary | Löe-Silness Gingival Index Score (GI) - Natural Teeth | Gingivitis score(GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding.Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score = adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Primary | Löe-Silness Gingival Index Score (GI)- Dental Implants | Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1=Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Primary | Löe-Silness Gingival Index Score (GI)- Dental Implants | Gingivitis Score (GI) is defined: 0 = Absence of inflammation,1 = Mild inflammation-slight change in color and little change in texture,2 = Moderate inflammation-moderate glazing,redness,edema & hypertrophy,3 = Severe inflammation-marked redness and hypertrophy tendency for spontaneous bleeding. Each tooth is scored on 6 surfaces:mesio-facial;2)mid-facial;3)disto-facial;4)mesio-lingual;5)mid-lingualand 6)disto-lingual. A whole mouth score=adding all the GI scores & dividing by the total of number of sites scored. 3rd molars and teeth with restorations or crowns will be excluded. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Primary | Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth | Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema; 3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing, change in color, obvious oedema;5=bleeding on probing, spontaneous bleeding, change in color, marked oedema. | Posted | Mean | Standard Deviation | Units on a scale | 3 months |
|
|
|
|
| Primary | Gingival Bleeding on Probing (BOP) Using Sulcus Bleeding Index for Teeth | Sulcus bleeding index for teeth is explained here. Gums around teeth are scored:0 = gingiva of normal texture & color, no bleeding;1 = gingiva normal, bleeds on probing;2 = bleeding on probing,change in color, no oedema;3 = bleeding on probing,change in color, slight oedema;4 = bleeding on probing,change in color, obvious oedema;5 = bleeding on probing, spontaneous bleeding,change in color,marked oedema. | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
|
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| Primary | Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants | Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. | Posted | Mean | Standard Deviation | Units on a scale | 3 months |
|
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| Primary | Gingival Bleeding on Probing (BOP) Using the Modified Sulcus Bleeding Index for Implants | Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding. | Posted | Mean | Standard Deviation | Units on a scale | 6 months |
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| Primary | A.Actinomycetemcomitans (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are Least means square (LSM)determined by baseline adjusted means including Standard Error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (Colony Forming Units) | 3 months |
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| Primary | A.Actinomycetemcomitans (DNA Probe Analysis)- Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | A.Actinomycetemcomitans (DNA Probe Analysis)- Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implant. Data point is Least means square (LSM) determined by baseline adjusted means including Standard Error of Means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | C.Rectus (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | C.Rectus (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | C.Rectus (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | C.Rectus (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | Capnocytophaga sp. (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | Capnocytophaga sp. (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | E.Corrodens (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | E.Corrodens (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | E.Corrodens (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | E.Corrodens (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | E.Saburreum (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | E.Saburreum (DNA Probe Analysis)- Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)detemined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | E.Saburreum (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | E.Saburreum (DNA Probe Analysis) - Dental Implant | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | F.Nucleatum (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | F.Nucleatum (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM) | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | F.Nucleatum (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | F.Nucleatum (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM)determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | Neissera sp. (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | Neissera sp. (DNA Probe Analysis) Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points least means square (LSM) determined by baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | Neissera sp. (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | Neissera sp. (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | P.Gingivalis (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM) | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | P.Gingivalis (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM) | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | P.Gingivalis (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM) | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | P.Gingivalis (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error of means (SEM) | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | P.Intermedia (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | P.Intermedia (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | P.Intermedia (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | P.Intermedia (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | P.Melaninogenica (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | P.Melaninogenica (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | P.Melaninogenica (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | P.Melaninogenica (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | Solobacterium (S.Moorei)(DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | Solobacterium (S.Moorei)(DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | Streptococci (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | Streptococci (DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | Streptococci (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | Streptococci (DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means )SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | T.Forsythia (DNA Probe Analysis)- Natural Teeth | 14 microorganisms were identified via DNA probe analysis for both natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | T.Forsythia (DNA Probe Analysis)-Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | T.Forsythia (DNA Probe Analysis)- Dental Implants | 14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | T.Forsythia (DNA Probe Analysis)- Dental Implants | 14 microorganisms were identified via DNA probe analysis for both Dental Implants. Data points are least means square (LSM) determined by using baseline adjusted means including standard error of means (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | Veillonella sp.(DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM) | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | Veillonella sp.(DNA Probe Analysis) - Natural Teeth | 14 microorganisms were identified via DNA probe analysis for natural teeth. Data points are least means square (LSM) determined by using baseline adjusted means including standard error (SEM). | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| Primary | Veillonella sp.(DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM) | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 3 months |
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| Primary | Veillonella sp.(DNA Probe Analysis) - Dental Implants | 14 microorganisms were identified via DNA probe analysis for Dental Implants. Data points are least means square (LSM) detemined by using baseline adjusted means including standard error (SEM) | Posted | Least Squares Mean | Standard Error | Log cfu (colony forming units) | 6 months |
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| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | B - Postive Control | fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment. | 0 | 50 | 0 | 50 |
Not provided
| Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |