Overview
This study investigates whether applying a chlorohexidine varnish (a dental coating) reduces gum overgrowth, plaque buildup, and early tooth decay (white spots) in patients with braces. Each participant's mouth is divided into two sides: one receives the active varnish, and the other receives a placebo. Changes in gum health, plaque, and white spots are tracked over 3 months.
Description
This split-mouth randomized controlled trial evaluates the clinical efficacy of 40% chlorohexidine varnish in reducing gingival hyperplasia, plaque buildup, and white spot lesions (WSLs) among orthodontic patients aged 15-30 years. The study employs a within patient design. Each participant's upper dental arch is divided into contralateral quadrants, randomly assigned (via coin flip) to receive either experimental (40% chlorohexidine varnish) or control (placebo: 60% sandarac/40% ethanol) treatments. The varnish is applied to buccal tooth surfaces and gingival margins at baseline (pre-bonding) and monthly for 3 months. Participants are blinded to treatment assignments and instructed to avoid eating/drinking for 3 hours post-application. Primary outcomes include gingival hyperplasia (Bokenkamp index), plaque accumulation.
The trial targets 22 participants (44 teeth sites), accounting for a 10% non-response rate, recruited from the Orthodontics Department of Sardar Begum Dental College (Peshawar). Exclusion criteria include craniofacial anomalies, pregnancy/lactation, drug allergies ( antibiotics, immunosuppressants), varnish component sensitivity, or mouth breathing. The study addresses a critical need for preventive oral care in orthodontics, where fixed appliances increase plaque retention and demineralization risks.
Eligibility
Inclusion Criteria:
- Patients aged 15-30 years
- Subjects of both genders
- Presence of permanent dentition
Exclusion Criteria:
- Craniofacial anomalies (cleft lip or palate)
- Pregnant and lactating mothers
- Patients at higher risk of drug allergies (antibiotics, anticoagulants, immunosuppressants, calcium channel blockers)
- Allergy to any component of the varnishes
- Mouth breathers