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COMPLETED
NCT07814898
PHASE4

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

Sponsor: University of Science and Technology, Yemen

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-02-14

Completion Date

2026-08-09

Last Updated

2026-09-11

Healthy Volunteers

Yes

Interventions

DRUG

Triclosan 0.3% toothpaste

participant will brush their teeth with triclosan and sodium fluoride toothpaste twice daily

DRUG

sodium fluoride 0.24% toothpaste

participant will brush their teeth twice daily

DRUG

Chlorhexidine 0.2% mouthwash

participant will brush and rinse their teeth with CHX mouthwash and sodium fluoride toothpaste

Locations (1)

Faculty of Dentistry

Sanaa, Sana'a City, Yemen