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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
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.
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.
Sardar Begum Dental College & Hospital
Peshawar, Khyber Pakhtunkhwa, Pakistan
RECRUITINGReduction in Gingival Hyperplasia
Change in gingival hyperplasia score from baseline (T0) to 3 months (T3), assessed using the Bokenkamp index.
Time frame: Baseline (T0) to 3 months (T3)
Reduction in Plaque Accumulation
Change in plaque index scores from baseline (T0) to 3 months (T3), using the Silness and Loe Plaque Index.
Time frame: Baseline (T0) to 3 months (T3)
Reduction in White Spot Lesion Severity
Change in white spot lesion score from baseline (T0) to 3 months (T3), assessed using the Gorelick Index.
Time frame: Baseline (T0) to 3 months (T3)
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