Triclosan as Adjunctive Therapy in the Plaque Control in Children From Generalized Aggressive Periodontitis Families.
Primary Purpose
Generalized Aggressive Periodontitis
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Triclosan
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Generalized Aggressive Periodontitis focused on measuring plaque control, bacteria, inflammation, familial aggregation, prevention
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.
Sites / Locations
- University of Campinas, UNICAMP
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
G1: Triclosan/health children
G2: Placebo/health children
G3: Triclosan/GAP children
G4: Placebo/GAP children
Arm Description
Children from health parents will use the triclosan toothpaste for 45 days.
Children from health parents will use the placebo toothpaste for 45 days.
Children from GAP parents will use the triclosan toothpaste for 45 days.
Children from GAP parents will use the placebo toothpaste for 45 days.
Outcomes
Primary Outcome Measures
Change of the baseline bledding on probing at 45 days
Bleeding induced at the depth of the gingival sulcus or periodontal pocket after probing
Secondary Outcome Measures
Change of the baseline plaque index at 45 days
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
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
Concentration of bacteria in the subgingival biofilm
Full Information
NCT ID
NCT03642353
First Posted
August 15, 2018
Last Updated
September 30, 2018
Sponsor
University of Campinas, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT03642353
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 30, 2016 (Actual)
Primary Completion Date
December 20, 2016 (Actual)
Study Completion Date
December 20, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Aggressive Periodontitis
Keywords
plaque control, bacteria, inflammation, familial aggregation, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G1: Triclosan/health children
Arm Type
Experimental
Arm Description
Children from health parents will use the triclosan toothpaste for 45 days.
Arm Title
G2: Placebo/health children
Arm Type
Placebo Comparator
Arm Description
Children from health parents will use the placebo toothpaste for 45 days.
Arm Title
G3: Triclosan/GAP children
Arm Type
Experimental
Arm Description
Children from GAP parents will use the triclosan toothpaste for 45 days.
Arm Title
G4: Placebo/GAP children
Arm Type
Placebo Comparator
Arm Description
Children from GAP parents will use the placebo toothpaste for 45 days.
Intervention Type
Drug
Intervention Name(s)
Triclosan
Other Intervention Name(s)
Colgate Total Advanced Toothpaste
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
Colgate Cavity Protection 0.76 % Toothpaste
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of the baseline bledding on probing at 45 days
Description
Bleeding induced at the depth of the gingival sulcus or periodontal pocket after probing
Time Frame
Baseline and 45 days for each test
Secondary Outcome Measure Information:
Title
Change of the baseline plaque index at 45 days
Description
Reduction in the amount of plaque accumulation around the gingival marginal after the therapy.
Time Frame
Baseline and 45 days for each test
Title
Change of the baseline inflamatory markers levels in gingival crevicular fluid (pg/uL) at 45 days
Description
Concentration of IL-1β, IL-4, IL-6, IL-8, IL-10, IL-17, TNF-α and INF-γ released in gingival crevicular fluid
Time Frame
Baseline and 45 days for each test
Title
Change in the Microbial composition at 45 days
Description
Concentration of bacteria in the subgingival biofilm
Time Frame
Baseline and 45 days for each test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato CV Casarin, Prof. Dr.
Organizational Affiliation
University of Campinas, UNICAMP
Official's Role
Study Chair
Facility Information:
Facility Name
University of Campinas, UNICAMP
City
Piracicaba
State/Province
Sao Paulo
ZIP/Postal Code
13414-903
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
31907625
Citation
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.
Results Reference
derived
Learn more about this trial
Triclosan as Adjunctive Therapy in the Plaque Control in Children From Generalized Aggressive Periodontitis Families.
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