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Clinical study to evaluate and compare the efficacy of two baking soda containing dentifrices, containing 20% and 35% baking soda, to a non-baking soda dentifrice for their ability to reduce gingivitis and plaque following 6-months of use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0% Baking Soda Dentifrice | Active Comparator |
| |
| 20% Baking Soda Dentifrice | Active Comparator |
| |
| 35% Baking Soda Dentifrice | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dentifrices | Drug | Dentifrice on plaque, gingivitis, and bleeding. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | Mean Within-Treatment Whole-Mouth Score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to entire marginal or papillary gingival unit, 3=moderate inflammation: glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit, 4=severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The scale ranges from 0-4. | baseline, six weeks, 3 months and 6 months |
| Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | Mean Within-Treatment Whole-Mouth Score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2. | baseline, six week, three months, and six months |
| Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | Mean Within-Treatment Whole-Mouth Score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown). The scale ranges from 0-5. | baseline, six weeks, three months, and six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All Sum Research Center Ltd. | Mississauga | Ontario | L4W OC2 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0% Baking Soda Dentifrice | Dentifrice, not containing baking soda, evaluated for ability to reduce gingivitis and plaque following 6-months of use. |
| FG001 | 20% Baking Soda Dentifrice | Dentifrice, containing 20% baking soda, evaluated for ability to reduce gingivitis and plaque following 6-months of use. |
| FG002 | 35% Baking Soda Dentifrice | Dentifrice, containing 35% baking soda, evaluated for ability to reduce gingivitis and plaque following 6-months of use. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0% Baking Soda Dentifrice | Dentifrices: Dentifrice on plaque, gingivitis, and bleeding. |
| BG001 | 20% Baking Soda Dentifrice | Dentifrices: Dentifrice on plaque, gingivitis, and bleeding. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | Mean Within-Treatment Whole-Mouth Score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to entire marginal or papillary gingival unit, 3=moderate inflammation: glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit, 4=severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The scale ranges from 0-4. | Posted | Mean | Standard Deviation | units on a scale | baseline, six weeks, 3 months and 6 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 | 0% Baking Soda Dentifrice | Dentifrices: Dentifrice on plaque, gingivitis, and bleeding. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Primary discomforts | General disorders | Systematic Assessment | Mild oral mucosal sloughing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Annahita Ghassemi, PhD | Church & Dwight Co., Inc | 6098061200 | annhita.ghassemi@churchdwight.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2018 | Mar 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D006470 | Hemorrhage |
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D003802 | Dentifrices |
| ID | Term |
|---|---|
| D001697 | Biomedical and Dental Materials |
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| BG002 | 35% Baking Soda Dentifrice | Dentifrices: Dentifrice on plaque, gingivitis, and bleeding. |
| BG003 | Total | Total of all reporting groups |
| Age |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gingvial Efficacy | Measure Description: Lobene Modified Loe-Silness Gingival Scoring Index (MGI) - gingival sites were visually scored at each visit on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth, using a scale of 0-4. Lower values represent a better outcome. | Mean | Full Range | units on a scale |
|
| Gingival Bleeding Efficacy | Measure Description: Bleeding was assessed on all scorable buccal and lingual surfaces by inserting a periodontal probe into the gingival crevice and sweeping from the distal aspect to the mesial aspect around the tooth at a depth of approximately 1 mm and angle of approximately 60 degrees while in contact with the sulcular epithelium. Three areas (distobuccal, midbuccal and midlingual) were assessed around each tooth. Sites were scored at each visit using the Gingival Bleeding Index (GBI) as defined by Saxton and van der Ouderaa on a scale of 0-2. Lower values represent a better outcome. | Mean | Full Range | units on a scale |
|
| Plaque Efficacy | Measure Description: Plaque was scored at each visit using the Soparker modification of the Turesky Modification of the Quigley-Hein Plaque Index (PI) on all scorable buccal and lingual surfaces. Plaque was stained with disclosant and each tooth was divided into six areas for scoring on a scale of 0-5. A PI score for each subject was calculated by adding all individual site scores (6 per tooth) and dividing by the total number of sites scored (teeth x 6). Lower values represent a better outcome. | Mean | Full Range | units on a scale |
|
| OG001 | 20% Baking Soda Dentifrice | Dentifrices: Dentifrice on plaque, gingivitis, and bleeding. |
| OG002 | 35% Baking Soda Dentifrice | Dentifrices: Dentifrice on plaque, gingivitis, and bleeding. |
|
|
| Primary | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | Mean Within-Treatment Whole-Mouth Score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2. | Posted | Mean | Standard Deviation | units on a scale | baseline, six week, three months, and six months |
|
|
|
| Primary | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | Mean Within-Treatment Whole-Mouth Score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown). The scale ranges from 0-5. | Posted | Mean | Standard Deviation | units on a scale | baseline, six weeks, three months, and six months |
|
|
|
| 0 |
| 103 |
| 0 |
| 103 |
| 4 |
| 103 |
| EG001 | 20% Baking Soda Dentifrice | Dentifrices: Dentifrice on plaque, gingivitis, and bleeding. | 0 | 105 | 0 | 105 | 17 | 105 |
| EG002 | 35% Baking Soda Dentifrice | Dentifrices: Dentifrice on plaque, gingivitis, and bleeding. | 0 | 107 | 0 | 107 | 2 | 107 |
| Primary discomforts | General disorders | Systematic Assessment | Mild Dry Mouth |
|
| Primary discomforts | General disorders | Systematic Assessment | Mild oral tingling/burning sensation |
|
| Primary discomforts | General disorders | Systematic Assessment | Mild sensitive/irritated gums/teeth |
|
Master service agreement and confidentiality agreement in place
| D009057 |
| Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Male |
|
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| 3 months |
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| 6 months |
|
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| 3 months 3 months |
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| 6 months |
|