Quantitative Measurement of the Adhesive Remnant Index Using Two Different Debonding Techniques: A Split-mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Adhesive remnant index
研究概览
简要总结
A crucial step at end of debonding is to evaluate the site of bond failure. An accurate assessment of the site of bond failure will allow the clinician to select an optimum method for adhesive remnant removal from the enamel surface.
The aim of this study is to do a randomized clinical trial to measure adhesive remanent index quantitively after debonding with wing and base method of debonding
详细描述
After informed consent data would be collected from patients who are undergoing debonding of orthodontic brackets after comprehensive orthodontic treatment of at least 2 years. Only the cases which have no loose anterior upper and lower brackets for the last 6 months would be randomly allocated to one of the two sides in each arch for debonding with a specific technique. A protocol of block randomization would be followed for this study. Debonding of brackets would be done either by wing or base method in a split fashion after removal of orthodontic wires. The patient would be explained that both methods are conventional used and are safe for debonding. After debonding each bracket the patient would be asked for the level of pain he felt during the debonding of that specific bracket. The patient will explain the pain level on a scale of 0-10 with 0 referring to no pain while 10 referring to maximum pain. After debonding a digital microscope (Supereyes) would be used along with plastic tubing for taking the adhesive remanent pictures intraorally from the labial surface of teeth. The plastic tubing would have a calibrated scale attached to it. For each new patient, a new tubing or disinfected tubing would be used. The available data would be measured extra orally on a computer-based software (ImageJ). Variable like age, gender, oral hygiene, ARI, side of adhesive flush, and pain would be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patients were blinded for the technique used in each quadrant and also the outcome assessors were blinded about the technique used for debonding brackets.
入排标准
- 年龄范围
- 12 Years 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All the patients undergoing comprehensive orthodontic treatment by fixed orthodontics
- •No reporting of bracket failure in the last 6 months.
- •Same company metal brackets used.
- •Same adhesive used with same bonding protcol
排除标准
- •Syndromic patient
- •An episode of bracket failure in the last six months
- •Short-term orthodontic treatment
结局指标
主要结局
Adhesive remnant index
时间窗: 6 months
Quantitative Measurement of adhesive remnant index by a digital handheld microscope
次要结局
- Patient reported outcome: Pain(6 months)
研究者
Haris Khan
Professor
CMH Lahore Medical And Dental College
