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临床试验/NCT07115784
NCT07115784已完成不适用

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

Khyber Medical University Peshawar1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年7月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Reduction in Gingival Hyperplasia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
15 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Chlorhexidine Varnish (Drug)

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.

干预措施: Placebo Varnish (Drug)

结局指标

主要结局

Reduction in Gingival Hyperplasia

时间窗: 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.

次要结局

  • Reduction in Plaque Accumulation(Baseline (T0) to 3 months (T3))
  • Reduction in White Spot Lesion Severity(Baseline (T0) to 3 months (T3))

研究者

发起方
Khyber Medical University Peshawar
申办方类型
Other
责任方
Sponsor

研究点 (1)

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