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Clinical Efficacy of Chlorhexidine Varnish in Reducing Gingival Hyperplasia, Plaque Accumulation, and White Spot Lesions in Orthodontic Patients

Clinical Efficacy of Chlorhexidine Varnish in Reducing Gingival Hyperplasia, Plaque Accumulation, and White Spot Lesions in Orthodontic Patients

Recruiting
18-30 years
All
Phase N/A

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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

Study details
    Gingival Hyperplasia
    Dental Plaque
    Tooth Demineralization

NCT07115784

Khyber Medical University Peshawar

4 September 2025

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