Triclosan as Adjunctive Therapy in the Plaque Control in Children From Generalized Aggressive Periodontitis Families.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03642353 |
Recruitment Status :
Completed
First Posted : August 22, 2018
Last Update Posted : October 2, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Generalized Aggressive Periodontitis | Drug: Triclosan Drug: Placebo | Phase 4 |
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 |

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 |
- 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 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
Brazil | |
University of Campinas, UNICAMP | |
Piracicaba, Sao Paulo, Brazil, 13414-903 |
Study Chair: | Renato CV Casarin, Prof. Dr. | University of Campinas, UNICAMP |
Responsible Party: | Renato Casarin, Principal Investigator, University of Campinas, Brazil |
ClinicalTrials.gov Identifier: | NCT03642353 |
Other Study ID Numbers: |
103/2015 |
First Posted: | August 22, 2018 Key Record Dates |
Last Update Posted: | October 2, 2018 |
Last Verified: | September 2018 |
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 |
plaque control bacteria inflammation familial aggregation prevention |
Periodontitis Aggressive Periodontitis Aggression Periodontal Diseases Mouth Diseases Stomatognathic Diseases Behavioral Symptoms Listerine Triclosan Sodium Fluoride |
Cariostatic Agents Protective Agents Physiological Effects of Drugs Anti-Infective Agents, Local Anti-Infective Agents Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |