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

NCT03642353 | Completed Phase 4

• 1 other identifier: 103/2015
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Aggressive Periodontitis

Keywords

plaque control; bacteria; inflammation; familial aggregation; prevention

Outcome Measures

Primary Outcomes (1)

• Change of the baseline bledding on probing at 45 days

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

  Baseline and 45 days for each test

Secondary Outcomes (3)

• Change of the baseline plaque index at 45 days

  Baseline and 45 days for each test

• Change of the baseline inflamatory markers levels in gingival crevicular fluid (pg/uL) at 45 days

  Baseline and 45 days for each test

• Change in the Microbial composition at 45 days

  Baseline and 45 days for each test

Study Arms (4)

G1: Triclosan/health children

EXPERIMENTAL

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

Drug: Triclosan

G2: Placebo/health children

PLACEBO COMPARATOR

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

Drug: Placebo

G3: Triclosan/GAP children

EXPERIMENTAL

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

Drug: Triclosan

G4: Placebo/GAP children

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Triclosan 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.

Also known as: Colgate Total Advanced Toothpaste

G1: Triclosan/health children; G3: Triclosan/GAP children

Placebo 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.

Also known as: Colgate Cavity Protection 0.76 % Toothpaste

G2: Placebo/health children; G4: Placebo/GAP children

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Present parents diagnosed with periodontal health or generalized aggressive periodontitis
• Present between 6 and 12 years old
• Present good general health

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

University of Campinas, UNICAMP

Piracicaba, São Paulo, 13414-903, Brazil

Location

Related Publications (1)

• 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.

  PMID: 31907625 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Triclosan; Toothpastes

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Dentifrices; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Renato CV Casarin, Prof. Dr.

  University of Campinas, UNICAMP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 22, 2018
• Study Start: January 30, 2016
• Primary Completion: December 20, 2016
• Study Completion: December 20, 2016
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

BR (1)