Triclosan as Adjunctive Therapy in the Plaque Control in Children From Generalized Aggressive Periodontitis Families.
Condition: Generalized Aggressive Periodontitis
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Study type: Interventional
Phase: Phase 4

Summary: 
      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: 
      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%.
    

Intervention name(s): Triclosan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Colgate Total Advanced Toothpaste; Colgate Cavity Protection 0.76 % Toothpaste
Intervention MeSH terms: Listerine; Triclosan; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: plaque control; bacteria; inflammation; familial aggregation; prevention