Clinical Efficacy of Chlorhexidine Varnish in Reducing Gingival Hyperplasia, Plaque Accumulation, and White Spot Lesions in Orthodontic Patients
NCT ID: NCT07115784
Last Updated: 2025-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
22 participants
INTERVENTIONAL
2025-07-21
2025-10-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Chlorhexidine Varnish
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.
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.
Placebo Varnish (Control Arm)
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Subjects of both genders
* Presence of permanent dentition
Exclusion Criteria
* 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
18 Years
30 Years
ALL
Yes
Sponsors
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Gandhara University
OTHER
Khyber Medical University Peshawar
OTHER
Responsible Party
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Principal Investigators
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Faryal Haider
Role: PRINCIPAL_INVESTIGATOR
Sardar Begum Dental College
Locations
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Sardar Begum Dental College & Hospital
Peshawar, Khyber Pakhtunkhwa, Pakistan
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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KMU/DIR/CTU/2025/004
Identifier Type: -
Identifier Source: org_study_id
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