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

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

Tracking Information
First Submitted Date  ICMJE August 15, 2018
First Posted Date  ICMJE August 22, 2018
Last Update Posted Date October 2, 2018
Actual Study Start Date  ICMJE January 30, 2016
Actual Primary Completion Date December 20, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Triclosan as Adjunctive Therapy in the Plaque Control in Children From Generalized Aggressive Periodontitis Families.
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Generalized Aggressive Periodontitis
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2018)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 20, 2016
Actual Primary Completion Date December 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03642353
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Renato Casarin, University of Campinas, Brazil
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Renato CV Casarin, Prof. Dr. University of Campinas, UNICAMP
PRS Account University of Campinas, Brazil
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP