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

NCT07115784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-05-07

No results posted yet for this study

Summary

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.

Conditions

  • Gingival Hyperplasia
  • Dental Plaque
  • Tooth Demineralization

Interventions

DRUG

Chlorhexidine Varnish

A 40% chlorhexidine varnish formulation (40% chlorhexidine, 36% sandarac, 24% ethanol) applied topically to the buccal surfaces of teeth in the selected upper quadrant. The varnish is applied using a blunt needle syringe before bonding and at monthly follow-up visits for three months. Teeth are dried before application, and patients are instructed not to eat or drink for 3 hours and to avoid brushing until the next day.

DRUG

Placebo Varnish

A placebo varnish composed of 60% sandarac and 40% ethanol applied topically in the same manner and frequency as the chlorhexidine varnish. Used on the opposite quadrant of the same patient in a split-mouth design. Participants are blinded to whether chlorhexidine or placebo was applied.

Sponsors & Collaborators

  • Gandhara University

    collaborator OTHER

  • Khyber Medical University Peshawar

    lead OTHER

Principal Investigators

  • Faryal Haider · Sardar Begum Dental College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
15 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-21
Primary Completion
2026-01-15
Completion
2026-02-15

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07115784 on ClinicalTrials.gov