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

NCT ID: NCT03642353

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-30
• Study Completion Date: 2016-12-20

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%.

Conditions

Generalized Aggressive Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

G1: Triclosan/health children

Children from health parents will use the triclosan toothpaste for 45 days.

Group Type: EXPERIMENTAL

Triclosan

Intervention Type: DRUG

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.

G2: Placebo/health children

Children from health parents will use the placebo toothpaste for 45 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

G3: Triclosan/GAP children

Children from GAP parents will use the triclosan toothpaste for 45 days.

Group Type: EXPERIMENTAL

Triclosan

Intervention Type: DRUG

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.

G4: Placebo/GAP children

Children from GAP parents will use the placebo toothpaste for 45 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Colgate Total Advanced Toothpaste; Colgate Cavity Protection 0.76 % Toothpaste

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Renato Casarin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renato CV Casarin, Prof. Dr.

Role: STUDY_CHAIR

University of Campinas, UNICAMP

Locations

University of Campinas, UNICAMP

Piracicaba, São Paulo, Brazil

Countries

Brazil

References

Monteiro MF, Tonelli H, Reis AA, Casati MZ, Silverio 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.

Reference Type: DERIVED

PMID: 31907625 (View on PubMed)

Other Identifiers

103/2015

Identifier Type: -

Identifier Source: org_study_id