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Trial record 75 of 256 for:    colgate

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

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.

Condition or disease Intervention/treatment Phase
Generalized Aggressive Periodontitis Drug: Triclosan Drug: Placebo Phase 4

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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Triclosan as Adjunctive Therapy in the Plaque Control in Children From Generalized Aggressive Periodontitis Families. A Controlled and Randomized Clinical Trial.
Actual Study Start Date : January 30, 2016
Actual Primary Completion Date : December 20, 2016
Actual Study Completion Date : December 20, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Triclosan

Arm Intervention/treatment
Experimental: G1: Triclosan/health children
Children from health parents will use the triclosan toothpaste for 45 days.
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

Placebo Comparator: G2: Placebo/health children
Children from health parents will use the placebo toothpaste for 45 days.
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

Experimental: G3: Triclosan/GAP children
Children from GAP parents will use the triclosan toothpaste for 45 days.
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

Placebo Comparator: G4: Placebo/GAP children
Children from GAP parents will use the placebo toothpaste for 45 days.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Change in the Microbial composition at 45 days [ Time Frame: Baseline and 45 days for each test ]
    Concentration of bacteria in the subgingival biofilm



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642353


Locations
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Brazil
University of Campinas, UNICAMP
Piracicaba, Sao Paulo, Brazil, 13414-903
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Study Chair: Renato CV Casarin, Prof. Dr. University of Campinas, UNICAMP

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Responsible Party: Renato Casarin, Principal Investigator, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT03642353     History of Changes
Other Study ID Numbers: 103/2015
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018

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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

Keywords provided by Renato Casarin, University of Campinas, Brazil:
plaque control
bacteria
inflammation
familial aggregation
prevention

Additional relevant MeSH terms:
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Listerine
Sodium Fluoride
Periodontitis
Aggression
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
Triclosan
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs