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

• ClinicalTrials.gov Identifier: NCT03642353
• Recruitment Status: Completed
• First Posted: August 22, 2018
• Last Update Posted: October 2, 2018
• Sponsor: University of Campinas, Brazil
• Information provided by (Responsible Party): Renato Casarin, University of Campinas, Brazil

Tracking Information

• First Submitted Date: August 15, 2018
• First Posted Date: August 22, 2018
• Last Update Posted Date: October 2, 2018
• Actual Study Start Date: January 30, 2016
• Actual Primary Completion Date: December 20, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 30, 2018)

Change of the baseline bledding on probing at 45 days [ Time Frame: Baseline and 45 days for each test ]

Bleeding induced at the depth of the gingival sulcus or periodontal pocket after probing

Original Primary Outcome Measures (submitted: August 20, 2018)

Change of the baseline plaque index at 45 days [ Time Frame: Baseline and 45 days for each test ]

Reduction in the amount of plaque accumulation around the gingival marginal after the therapy.

Current Secondary Outcome Measures (submitted: September 30, 2018)

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

Original Secondary Outcome Measures (submitted: August 20, 2018)

• Change of the baseline bledding on probing at 45 days [ Time Frame: Baseline and 45 days for each test ]
  bleeding induced at the depth of the gingival sulcus or periodontal pocket after probing
• Change of the baseline inflamatory markers levels in gingival crevicular fluid (pg/uL) at 45 days [ Time Frame: Baseline and 45 days for each test ]
  Concentration of IL-1β, IL-4, IL-6, IL-8, IL-10, IL-17, TNF-α and INF-γ released in gingival crevicular fluid
• Change in the Microbial composition at 45 days [ Time Frame: Baseline and 45 days for each test ]
  Concentration of bacteria in the subgingival biofilm

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Triclosan as Adjunctive Therapy in the Plaque Control in Children From Generalized Aggressive Periodontitis Families.
• Official Title: Triclosan as Adjunctive Therapy in the Plaque Control in Children From Generalized Aggressive Periodontitis Families. A Controlled and Randomized Clinical Trial.
• Brief 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%.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Generalized Aggressive Periodontitis

Intervention

• Drug: Triclosan
  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 Name: Colgate Total Advanced Toothpaste
• Drug: Placebo
  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 Name: Colgate Cavity Protection 0.76 % Toothpaste

Study Arms

• Experimental: G1: Triclosan/health children
  Children from health parents will use the triclosan toothpaste for 45 days.
  Intervention: Drug: Triclosan
• Placebo Comparator: G2: Placebo/health children
  Children from health parents will use the placebo toothpaste for 45 days.
  Intervention: Drug: Placebo
• Experimental: G3: Triclosan/GAP children
  Children from GAP parents will use the triclosan toothpaste for 45 days.
  Intervention: Drug: Triclosan
• Placebo Comparator: G4: Placebo/GAP children
  Children from GAP parents will use the placebo toothpaste for 45 days.
  Intervention: Drug: Placebo

• Publications *: Monteiro MF, Tonelli H, Reis AA, Casati MZ, Silvério KG, Nociti Junior FH, Sallum EA, Casarin RCV. Triclosan toothpaste as an adjunct therapy to plaque control in children from periodontitis families: a crossover clinical trial. Clin Oral Investig. 2020 Apr;24(4):1421-1430. doi: 10.1007/s00784-019-03121-6. Epub 2020 Jan 6.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 20, 2018): 40
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 20, 2016
• Actual Primary Completion Date: December 20, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 12 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT03642353
• Other Study ID Numbers: 103/2015
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Renato Casarin, University of Campinas, Brazil
• Study Sponsor: University of Campinas, Brazil
• Collaborators: Not Provided

Investigators

• Study Chair: Renato CV Casarin, Prof. Dr.; University of Campinas, UNICAMP

• PRS Account: University of Campinas, Brazil
• Verification Date: September 2018