drugset / Trial / NCT07814898

Comparison Between the Effect of Triclosan Toothpaste and Chlorhexidine Mouthwash on Gingival Health in a Group of Fixed Orthodontic Patients: A Randomized Controlled Clinical Trial

NCT07814898 ↗

Phase 4 Completed 60 enrolled University of Science and Technology, Yemen
RandomizedSequentialDouble-blindPrevention

Summary

Study Protocol Introduction Title of the research study Comparison Between the effect of Triclosan Toothpaste and chlorhexidine Mouthwash on Gingival Health in Fixed Orthodontic Patients :A randomization controlled clinical trial. Background Orthodontic brackets and elastics might interfere with effective removal of dental plaque, thereby increasing the risk of gingivitis. The aim of this study to compare the effect of triclosan toothpaste and chlorhexidine mouthwash on gingival health in a group of fixed orthodontic patients. Procedures Participant eligibility will be assessed based on a dental examination, medical history and inclusion and exclusion criteria. Inclusion criteria: * Patient age 18-35 years old. * Orthodontic patient in leveling and alignment stage. * Interested, cooperative fixed orthodontic patients who are aware of the importance of using toothpastes and mouthwash during orthodontic treatment. * Patients who have good oral hygiene during orthodontic treatment. * Medically fit patients who are not using any medical treatment that may affect periodontal health such as (antibiotic, phenytoin). * Class I, II, III malocclusion with mild to moderate crowding. Exclusion criteria: * Patients with systemic disease affecting periodontal health such as (lichen planus, pemphigus) * Smoker patients. * Chewing qat patients. Eligible participants will be randomly assigned to one of three groups Group 1: will use Colgate Total® toothpaste containing sodium fluoride 0.24% and Triclosan 0.3% for one month twice a day. Group 2: will use Maxfresh ® toothpaste containing sodium fluoride 0.24% in addition to Hexadyl® Chlorhexidine mouthwash for one month twice a day. Group 3: will brush their teeth by Colgate Maxfresh ® toothpaste containing sodium fluoride 0.24% for 3 month twice a day. The participant will be instructed to brush and rinse his or her teeth twice a day and they must follow orthodontic treatment instructions to maintain the braces. The study will last for three month.

Timeline

Start
2026-02-14
Primary completion
2026-05-09
Completion
2026-08-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine Small molecule 0.2 % Oral
Subject Triclosan Small molecule 0.3 % Oral
Comparator sodium fluoride Unknown 0.24 % Oral

Indications