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 | Completed Phase 4 DMC

• 1 other identifier: 1447/0090/UREC/UST
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingival Inflammation

Outcome Measures

Primary Outcomes (1)

• gingival index

  evaluation of gingival index using the Loe and Sinless gingival index

  at baseline, one month, two months, three months.

Secondary Outcomes (1)

• plaque index

  at baseline, one month, two months, three months.

Study Arms (3)

Triclosan toothpaste with sodium fluoride

EXPERIMENTAL

participants will brush their teeth twice daily

Drug: Triclosan 0.3% toothpaste

CHX Mouthwash Group with sodium fluoride toothpaste

EXPERIMENTAL

participants will brush and rinsing their teeth twice daily

Drug: Chlorhexidine 0.2% mouthwash

control Group sodium fluoride toothpaste

ACTIVE COMPARATOR

participants will brush their teeth twice daily

Drug: sodium fluoride 0.24% toothpaste

Interventions

Triclosan 0.3% toothpaste DRUG

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

Triclosan toothpaste with sodium fluoride

sodium fluoride 0.24% toothpaste DRUG

participant will brush their teeth twice daily

control Group sodium fluoride toothpaste

Chlorhexidine 0.2% mouthwash DRUG

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

CHX Mouthwash Group with sodium fluoride toothpaste

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient age 18-35 years old.
• 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.

You may not qualify if:

• \- Patients with systemic disease affecting periodontal health such as (lichen planus, pemphigus)
• Smoker patients.
• Chewing qat patients.

Sponsors & Collaborators

• University of Science and Technology, Yemen: lead

Study Sites (1)

Faculty of Dentistry

Sanaa, Sana'a City, Yemen

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Triclosan; Toothpastes; Sodium Fluoride; Chlorhexidine; Mouthwashes

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

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; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biguanides; Guanidines; Amidines; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist/Postgraduate student/Master's student

Model Details: The participants will be selected according to inclusion \&exclusion criteria and they will be divided in to three groups and will be given instructions as follows: * Group I (Triclosan group): will brush their teeth by Colgate Total® toothpaste containing sodium fluoride 0.24% and Triclosan 0.3% for 3 month twice a day. * Group II (CHX group): will brush their teeth by Colgate maxfresh ® toothpaste containing sodium fluoride 0.24% in addition to Hexadyl® Chlorhexidine mouthwash for 3 month twice a day. * Group III (Controlled group): will brush their teeth by Colgate maxfresh ® toothpaste containing sodium fluoride 0.24% for 3 month twice a day. The selected toothpaste and mouthwash will be provided for all participants free of charge. Figure (

Study Record Dates

• First Submitted: September 5, 2026
• First Posted: September 11, 2026
• Study Start: February 14, 2026
• Primary Completion: May 9, 2026
• Study Completion: August 9, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

YE (1)