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This study evaluates the anti-inflammatory effects of Colgate Total® during an experimental gingivitis model developed by Löe et al. Half of the participants will use Colgate Total® (which contains triclosan), while the other half will use a toothpaste which does not contain triclosan as the control.
This will be a double-blind. Subjects will be randomly assigned to the test or control dentifrice arm. Enrolled subjects will also be randomly assigned to either right or left side mandibular stent.
During the induction phase (i.e., day 0 to day 21), participants are instructed to refrain from all hygiene procedures in the stent area. During this time period, participants evenly distributed 2mL of their assigned dentifrice into their stent, allowing it to come into contact with the areas of experimental gingivitis for two minutes twice daily while traditional tooth brushing was performed in the non-stent areas. Clinical measures, saliva, gingival crevicular fluid and plaque samples will be collected at days 0, 14, 21, and 35 study visits. A randomization chart will be used to identify which two sites (teeth and tooth surface) will be used at the specific study visit for collection of gingival crevicular fluid(GCF) and plaque.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toothpaste without Triclosan | Active Comparator | This arm will use a toothpaste that does not contain triclosan |
|
| Triclosan | Experimental | This arm will use colgate total which contains triclosan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toothpaste without triclosan | Other | this intervention will use a toothpaste without triclosan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35 | Silness & Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35. | Baseline to 35 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35 | Loe & Silness 1963 is a score of 0-3 with 0 = Absence of inflammation, 1 = Mild inflammation, slight change in color and texture, 2 = Moderate inflammation, glazing, redness, edema and hypertrophy, 3 = Severe inflammation, redness and hypertrophy, ulceration. This index was used at days 0, 14, 21 and 35. | Baseline to 35 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression. | Inflammatory biomarker expression will be quantified using a custom human 10-complex protein array that is optimized for sensitivity, specificity, stability, and intraassay coefficient of variation by comparing to single cytokine enzyme-linked immunosorbent assays (Quantibody Custom Array, RayBiotech, Norcross, GA). | Baseline to 35 Days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Kinney, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Center for Oral Health Research | Ann Arbor | Michigan | 48106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26820239 | Derived | Pancer BA, Kott D, Sugai JV, Panagakos FS, Braun TM, Teles RP, Giannobile WV, Kinney JS. Effects of triclosan on host response and microbial biomarkers during experimental gingivitis. J Clin Periodontol. 2016 May;43(5):435-44. doi: 10.1111/jcpe.12519. Epub 2016 Apr 6. |
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Initially 15 participants were sought for each arm, but when two were withdrawn from the control arm, two more participants were recruited and randomized, one to each arm. So total start on each arm was 16.
The Disqualification noted below for one participant was because s/he no longer met inclusion criteria as of day 14.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste). |
| FG001 | Test Arm | Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35 | Loe & Silness 1963 is a score of 0-3 with 0 = Absence of inflammation, 1 = Mild inflammation, slight change in color and texture, 2 = Moderate inflammation, glazing, redness, edema and hypertrophy, 3 = Severe inflammation, redness and hypertrophy, ulceration. This index was used at days 0, 14, 21 and 35. | Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice). | Posted | Mean | Standard Error | units on a scale | Baseline to 35 Days |
|
All adverse event data was collected for 9 months.
Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).
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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 | Control Arm | Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphthous ulcer | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Kinney | UMichigan | 734-615-5452 | kinneyj@umich.edu |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D014100 | Toothpastes |
| D014260 | Triclosan |
| C546060 | hydrated silica gel-based toothpaste |
| ID | Term |
|---|---|
| D003802 | Dentifrices |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Triclosan | Other | this intervention will use Colgate Total which contains triclosan |
|
|
| Plaque Samples Will be Collected for Bacterial Species Detection. | Supra- and sub-gingival plaque samples will be gently collected using a sterile curet and a one stroke method from two randomized sites within the stent area. The detection of 40 bacterial species will be evaluated by the checkerboard DNA-DNA hybridization technique originally described by Socransky et al. 1994. | Baseline to 35 Days |
| Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression. | A total of 10 biomarkers will be analyzed based on the results from Lee and colleagues: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, and TIMP-2. | Baseline to 35 Days |
| BG001 | Test Arm | Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Bleeding on probing ≤ 10% | Mean | Full Range | Percent of sites bleeding on probing |
|
| OG001 | Test Arm | Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste). |
|
|
| Primary | Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35 | Silness & Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35. | Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice). | Posted | Mean | Standard Error | units on a scale | Baseline to 35 Days |
|
|
|
| Other Pre-specified | Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression. | Inflammatory biomarker expression will be quantified using a custom human 10-complex protein array that is optimized for sensitivity, specificity, stability, and intraassay coefficient of variation by comparing to single cytokine enzyme-linked immunosorbent assays (Quantibody Custom Array, RayBiotech, Norcross, GA). | Not Posted | Baseline to 35 Days |
| Other Pre-specified | Plaque Samples Will be Collected for Bacterial Species Detection. | Supra- and sub-gingival plaque samples will be gently collected using a sterile curet and a one stroke method from two randomized sites within the stent area. The detection of 40 bacterial species will be evaluated by the checkerboard DNA-DNA hybridization technique originally described by Socransky et al. 1994. | Not Posted | Baseline to 35 Days |
| Other Pre-specified | Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression. | A total of 10 biomarkers will be analyzed based on the results from Lee and colleagues: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, and TIMP-2. | Not Posted | Baseline to 35 Days |
| 0 |
| 16 |
| 4 |
| 16 |
| EG001 | Test Arm | Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste). | 0 | 16 | 8 | 16 |
| Tissue slough | General disorders | Non-systematic Assessment |
|
| TMJ soreness | General disorders | Non-systematic Assessment |
|
| Tooth decay | General disorders | Non-systematic Assessment |
|
| Tingling in tongue | General disorders | Non-systematic Assessment |
|
| Toothbrush trauma | General disorders | Non-systematic Assessment |
|
| Herpetic lesion | General disorders | Non-systematic Assessment |
|
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| D009057 |
| Stomatognathic Diseases |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Plaque index Day 21 |
|
| Plaque index Day 35 |
|