RecruitingNot ApplicableNCT07115784

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

Clinical Efficacy of Chlorohexidine Varnish in Reducing Gingival Hyperplasia, Plaque Accumulation, and White-Spot Lesions in Orthodontic Patients: A Split-Mouth Randomised Controlled Trial


Sponsor

Khyber Medical University Peshawar

Enrollment

22 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 30 Years

Inclusion Criteria3

  • Patients aged 15-30 years
  • Subjects of both genders
  • Presence of permanent dentition

Exclusion Criteria5

  • 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

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Interventions

DRUGChlorhexidine 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.

DRUGPlacebo 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.


Locations(1)

Sardar Begum Dental College & Hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

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NCT07115784


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