Dental Plaque, Gingival Hyperplasia, Tooth Demineralization
Conditions
Keywords
Gingival Hyperplasia, Dental Plaque, Enamel decalcification, Gingival overgrowth
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.
Detailed description
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.
Interventions
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.
Sponsors
Khyber Medical University Peshawar
Gandhara University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Gingival Hyperplasia | 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 1. = Mild overgrowth 2. = Moderate overgrowth 3. = Severe overgrowth Direction: Higher scores indicate worse gingival hyperplasia; a reduction in score reflects clinical improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Plaque Accumulation | 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 1. = Thin film of plaque (visible only on probing) 2. = Moderate accumulation visible to the naked eye 3. = Abundant plaque accumulation Direction: Higher scores indicate worse plaque accumulation; a reduction in score reflects improvement in oral hygiene. |
| Reduction in White Spot Lesion Severity | 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 1. = Slight white spot formation 2. = Excessive white spot formation 3. = White spot formation with cavitation Direction: Higher scores indicate more severe enamel demineralization; a reduction in score reflects improvement. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORFaryal Haider
Sardar Begum Dental College
Outcome results
None listed