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

NCT07115784 | Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2025/004
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gingival Hyperplasia; Dental Plaque; Enamel decalcification; Gingival overgrowth

Outcome Measures

Primary Outcomes (1)

• Reduction in Gingival Hyperplasia

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

  Baseline (T0) to 3 months (T3)

Secondary Outcomes (2)

• Reduction in Plaque Accumulation

  Baseline (T0) to 3 months (T3)

• Reduction in White Spot Lesion Severity

  Baseline (T0) to 3 months (T3)

Study Arms (2)

Chlorhexidine Varnish

EXPERIMENTAL

Participants receive 40% chlorhexidine varnish applied to one upper quadrant. The varnish formulation includes 40% chlorhexidine, 36% sandarac, and 24% ethanol. It is applied using a blunt syringe to the buccal surfaces around orthodontic brackets before bonding and during each monthly follow-up for 3 months. Teeth are dried with compressed air prior to application, and patients are advised not to eat/drink for 3 hours and to avoid brushing until the next day.

Drug: Chlorhexidine Varnish

Placebo Varnish (Control Arm)

ACTIVE COMPARATOR

Participants receive placebo varnish (containing 60% sandarac and 40% ethanol) applied to the opposite upper quadrant using the same technique and schedule as the intervention arm. This serves as the control in the split-mouth design. Patients are blinded to which side received the active or placebo varnish.

Drug: Placebo Varnish

Interventions

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.

Chlorhexidine Varnish

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.

Placebo Varnish (Control Arm)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead
• Gandhara University: collaborator

Study Sites (1)

Sardar Begum Dental College & Hospital

Peshawar, Khyber Pakhtunkhwa, 09152, Pakistan

RECRUITING

Related Publications (6)

• Trombelli L, Farina R, Silva CO, Tatakis DN. Plaque-induced gingivitis: Case definition and diagnostic considerations. J Clin Periodontol. 2018 Jun;45 Suppl 20:S44-S67. doi: 10.1111/jcpe.12939.

  PMID: 29926492 BACKGROUND

• Lara-Carrillo E, Montiel-Bastida NM, Sanchez-Perez L, Alanis-Tavira J. Effect of orthodontic treatment on saliva, plaque and the levels of Streptococcus mutans and Lactobacillus. Med Oral Patol Oral Cir Bucal. 2010 Nov 1;15(6):e924-9. doi: 10.4317/medoral.15.e924.

  PMID: 20383105 BACKGROUND

• Grover V, Kapoor A, Malhotra R, Battu VS, Bhatia A, Sachdeva S. To assess the effectiveness of a chlorhexidine chip in the treatment of chronic periodontitis: A clinical and radiographic study. J Indian Soc Periodontol. 2011 Apr;15(2):139-46. doi: 10.4103/0972-124X.84383.

  PMID: 21976838 BACKGROUND

• Rai P, Pandey RK, Khanna R. Qualitative and Quantitative Effect of a Protective Chlorhexidine Varnish Layer Over Resin-infiltrated Proximal Carious Lesions in Primary Teeth. Pediatr Dent. 2016;38(4):40-5.

  PMID: 27557913 BACKGROUND

• Bretz WA, Valente MI, Djahjah C, do Valle EV, Weyant RJ, Nor JE. Chlorhexidine varnishes prevent gingivitis in adolescents. ASDC J Dent Child. 2000 Nov-Dec;67(6):399-402, 374.

  PMID: 11204062 BACKGROUND

• Alavi S, Yaraghi N. The effect of fluoride varnish and chlorhexidine gel on white spots and gingival and plaque indices in fixed orthodontic patients: A placebo-controlled study. Dent Res J (Isfahan). 2018 Jul-Aug;15(4):276-282.

  PMID: 30123305 BACKGROUND

MeSH Terms

Conditions

Gingival Hyperplasia; Dental Plaque; Tooth Demineralization; Gingival Overgrowth

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Officials

• Faryal Haider

  Sardar Begum Dental College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faryal Haider

CONTACT

3331124747; faryalhaider9@gmail.com

Prof Dr Nazir Ahmad

CONTACT

‪+923012210084; nazirahmad_dr@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to the side of varnish application (placebo vs chlorhexidine). Outcomes assessors evaluate standardized photographs and index scores without knowledge of group assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a specific type of cross-over design where different interventions are applied to different parts of the mouth in the same individual. Each patient will receive chlorhexidine varnish on one quadrant of the upper arch (experimental group) and placebo on the other quadrant (control group), using random allocation by coin flip.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 11, 2025
• Study Start: July 21, 2025
• Primary Completion: September 29, 2025
• Study Completion: October 15, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD and supporting documents will be available 6 months after publication of the primary results and will remain available for up to 3 years.
• Access Criteria: Researchers must submit a written request outlining the purpose of data use, research objectives, and intended outcomes. Requests will be reviewed by the principal investigator and ethics committee. Data will be shared under a data use agreement ensuring confidentiality and ethical use.

Locations

PA (1)