Triclosan as Adjunctive Therapy in the Plaque Control in Children From Generalized Aggressive Periodontitis Families.

Study Overview
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Brief Summary
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Generalized aggressive periodontitis (GAP) is an inflammatory disease that causes the severe and rapid destruction of periodontal tissue. A relatively constant microbiological pattern, an altered inflammatory condition and familial aggregation of cases were described as important characteristics of this disease. In this vein, studies evaluating children of GAP patients were made and identified early microbiological and inflammatory alterations in this population, suggesting that these factors could favor the disease development. Thus, the aim of this project is to evaluate if the use of toothpaste with Triclosan could have a beneficial effect in control the microbiota and the inflammatory condition in children from parents with GAP, comparing them to children of periodontally healthy parents. 20 children (6-12 years old) from GAP parents and 20 children (6-12 years old) from periodontally healthy parents will be selected and will participate in a cross-over placebo study. All children will be included in a 15-day period of control of plaque to standardize the hygiene technique using only the placebo toothpaste. After this period, the children will be divided randomly into 4 groups: G1: Triclosan/health children; G2: Placebo/health children; G3: Triclosan/GAP children; G4: Placebo/GAP children and they will use the specific paste described for each group for 45 days. After this period, all children will repeat the 15 days interval, using only the placebo toothpaste, to remove the Triclosan effect and to standardize the oral hygiene again. Posteriorly, the crossing of groups will be done and children will be reallocated to change the used toothpaste. Thus, children that were in G1 will be reallocated in G2, children of G2 will be reallocated in G1, children of G3 will be in G4 and children of G4 will be in G3, staying in this new group for more 45 days. The evaluated periods will be baseline, 15 days, 30 days and 45 days while children stay in G1, G2, G3 or G4. In these periods children will be clinically evaluated for the periodontal parameter and sample collection of crevicular gingival fluid (GCF) and subgingival biofilm from incisors and molars will be done. Luminex/MAGpix technology will be used to detect IL-1β, IL-4, IL-6, IL-8, IL-10, IL-17, TNF-α, INF-γ in the GCF. The subgingival biofilm will be used to evaluate the Porphyromonas gingivalis, Tannerella forsythia, Aggregatibacter actinomycetemcomitans levels by real-time PCR.

Detailed Description
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The data from each group will be compared by Student's t-test, Mann-Whitney test and chi-square test and a correlation between the inflammatory markers level and the subgingival bacterial concentration will be evaluated by Spearman's correlation and regression analysis. The significance level for all analysis will be 5%.

Official Title
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Triclosan as Adjunctive Therapy in the Plaque Control in Children From Generalized Aggressive Periodontitis Families. A Controlled and Randomized Clinical Trial.

Conditions
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Generalized Aggressive Periodontitis

Intervention / Treatment
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* Drug: Triclosan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present parents diagnosed with periodontal health or generalized aggressive periodontitis Present between 6 and 12 years old Present good general health Exclusion Criteria: The use of antibiotics or anti-inflammatories 6 months before the beginning of the study. Any Any change in the child's motor condition that interferes with the performance of appropriate hygiene procedures.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G1: Triclosan/health children<br>Children from health parents will use the triclosan toothpaste for 45 days. | Drug: Triclosan<br>* Children will be included in a cross-over study with control of plaque using Triclosan/placebo toothpaste for 4 months. Each child will be tested for placebo toothpaste for 45 days and for Triclosan toothpaste for more 45 days. At the beginning of each test, they will be included in a washout period with placebo toothpaste for 15 days.<br>* Other names: Colgate Total Advanced Toothpaste;|
| Placebo Comparator: G2: Placebo/health children<br>Children from health parents will use the placebo toothpaste for 45 days. | Drug: Placebo<br>* Children will be included in a cross-over study with control of plaque using Triclosan/placebo toothpaste for 4 months. Each child will be tested for placebo toothpaste for 45 days and for Triclosan toothpaste for more 45 days. At the beginning of each test, they will be included in a washout period with placebo toothpaste for 15 days.<br>* Other names: Colgate Cavity Protection 0.76 % Toothpaste;|
| Experimental: G3: Triclosan/GAP children<br>Children from GAP parents will use the triclosan toothpaste for 45 days. | Drug: Triclosan<br>* Children will be included in a cross-over study with control of plaque using Triclosan/placebo toothpaste for 4 months. Each child will be tested for placebo toothpaste for 45 days and for Triclosan toothpaste for more 45 days. At the beginning of each test, they will be included in a washout period with placebo toothpaste for 15 days.<br>* Other names: Colgate Total Advanced Toothpaste;|
| Placebo Comparator: G4: Placebo/GAP children<br>Children from GAP parents will use the placebo toothpaste for 45 days. | Drug: Placebo<br>* Children will be included in a cross-over study with control of plaque using Triclosan/placebo toothpaste for 4 months. Each child will be tested for placebo toothpaste for 45 days and for Triclosan toothpaste for more 45 days. At the beginning of each test, they will be included in a washout period with placebo toothpaste for 15 days.<br>* Other names: Colgate Cavity Protection 0.76 % Toothpaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the baseline bledding on probing at 45 days | Bleeding induced at the depth of the gingival sulcus or periodontal pocket after probing | Baseline and 45 days for each test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the baseline plaque index at 45 days | Reduction in the amount of plaque accumulation around the gingival marginal after the therapy. | Baseline and 45 days for each test | 
| Change of the baseline inflamatory markers levels in gingival crevicular fluid (pg/uL) at 45 days | Concentration of IL-1β, IL-4, IL-6, IL-8, IL-10, IL-17, TNF-α and INF-γ released in gingival crevicular fluid | Baseline and 45 days for each test | 
| Change in the Microbial composition at 45 days | Concentration of bacteria in the subgingival biofilm | Baseline and 45 days for each test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, plaque control, bacteria, inflammation, familial aggregation