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Completed

NCT Number: NCT07115784

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

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.

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Key information

Conditions

Gingival Hyperplasia Dental Deposits Dental Plaque Gingival Diseases Gingival Overgrowth Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sardar Begum Dental College & Hospital

Peshawar, Khyber Pakhtunkhwa, 09152, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorhexidine Varnish

Drug

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.

Placebo Varnish

Drug

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.

Primary outcomes

  1. Reduction in Gingival Hyperplasia

    Time frame: Baseline (T0) to 3 months (T3)

    Change in gingival hyperplasia score from baseline (T0) to 3 months (T3), assessed using the Bokenkamp Index.

    Scale range: 0 to 3

    Interpretation:

    0 = No gingival overgrowth

    • = Mild overgrowth
    • = Moderate overgrowth
    • = Severe overgrowth Direction: Higher scores indicate worse gingival hyperplasia; a reduction in score reflects clinical improvement.

Secondary outcomes

  1. Reduction in Plaque Accumulation

    Time frame: Baseline (T0) to 3 months (T3)

    Change in plaque index scores from baseline (T0) to 3 months (T3), assessed using the Silness and Löe Plaque Index.

    Scale range: 0 to 3

    Interpretation:

    0 = No plaque

    • = Thin film of plaque (visible only on probing)
    • = Moderate accumulation visible to the naked eye
    • = Abundant plaque accumulation Direction: Higher scores indicate worse plaque accumulation; a reduction in score reflects improvement in oral hygiene.

  2. Reduction in White Spot Lesion Severity

    Time frame: Baseline (T0) to 3 months (T3)

    Change in white spot lesion score from baseline (T0) to 3 months (T3), assessed using the Gorelick Index.

    Scale range: 0 to 3

    Interpretation:

    0 = No white spot lesion

    • = Slight white spot formation
    • = Excessive white spot formation
    • = White spot formation with cavitation Direction: Higher scores indicate more severe enamel demineralization; a reduction in score reflects improvement.

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Collaborators

  • Gandhara University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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