Effect of Different Adhesive Removal Techniques After Orthodontic Bracket Debonding on Postoperative Hypersensitivity: A Randomized Clinical Trial
The objective of this randomized clinical trial is to evaluate and compare the effect of four different residual adhesive removal techniques following orthodontic bracket debonding on postoperative tooth hypersensitivity. The study compares low-speed tungsten carbide burs against fiberglass burs, white stone burs, and rubber-impregnated polishing points. Postoperative hypersensitivity will be evaluated using a Visual Analogue Scale (VAS) with an air-blast stimulus test immediately after debonding, at 24 hours, and at 7 days follow-up.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Asmaa Badr Abdelfatah, BDS
- 电话号码：+20 1148106593
- 邮箱：asmaa.abdelfatah@dentistry.cu.edu.eg
研究联系人备份
- 姓名：Heba El-Deeb, PhD
- 电话号码：+20 106 610 9461
- 邮箱：heba.eldeeb@dentistry.cu.edu.eg
学习地点
-
-
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Cairo、埃及
- Faculty of Dentistry, Cairo University
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients of any gender aged 15 to 45 years undergoing routine fixed labial orthodontic bracket removal across anterior and premolar teeth in both jaws.
- Systemically healthy patients.
- Good oral hygiene with a healthy, intact periodontium without clinical attachment loss or gingival recession.
- Patients capable of reliably recording subjective discomfort on a Visual Analogue Scale (VAS) and willing to attend follow-up visits.
- Sound fully erupted permanent incisors, canines, and premolars bonded with conventional stainless steel labial brackets.
- Labial enamel surfaces free of visible pre-existing enamel defects, structural hypoplasia, severe fluorosis, or restorations.
Exclusion Criteria:
- Active use of systemic analgesics, NSAIDs, corticosteroids, or centrally acting pain medications within 14 days prior to debonding.
- Use of desensitizing toothpastes, mouthwashes, or topical fluoride varnishes within 30 days prior to the trial.
- Heavy bruxism, clenching habits, or pathological wear/erosion extending into dentin.
- Pregnant or lactating female patients.
- Teeth with irreversible pulpitis, pulpal necrosis, history of endodontic treatment, or periapical pathology.
- Teeth with active carious lesions or exposed cervical dentin/cementum.
- Teeth with severe, deep enamel microcracks identified at baseline examination.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Active Comparator: Low-Speed Tungsten Carbide Bur
Residual composite adhesive remnants on eligible teeth are cleaned using a 12-fluted low-speed tungsten carbide bur operated at 15,000-20,000 rpm under continuous water cooling. |
Composite resin is removed using a 12-fluted tapered low-speed tungsten carbide bur operated at 15,000-20,000 rpm under continuous air-water spray irrigation until all visible adhesive remnant is completely eliminated. |
|
实验性的：Fiberglass Bur
Residual composite adhesive remnants on eligible teeth are cleaned using a fiberglass bur operated at 15,000-20,000 rpm under continuous water cooling |
Composite resin remnants are eliminated using a fiberglass resin-removal bur operated at 15,000-20,000 rpm under continuous air-water spray irrigation until all visible material is completely removed. |
|
实验性的：White Stone Bur
Residual composite adhesive remnants on eligible teeth are cleaned using a fine-grit white stone bur (aluminum oxide) operated at 10,000-15,000 rpm under continuous water cooling. |
Composite resin remnants are removed using a fine-grit Arkansas white stone bur (aluminum oxide) operated at 10,000-15,000 rpm under continuous air-water spray irrigation until the enamel surface is clear. |
|
实验性的：Rubber-Impregnated Polishing Point
Residual composite adhesive remnants on eligible teeth are cleaned using a rubber-impregnated polishing point operated at 10,000-15,000 rpm under continuous water cooling |
Residual adhesive tags are removed and polished using a rubber-impregnated composite polishing point operated at 10,000-15,000 rpm under continuous air-water spray irrigation |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative Hypersensitivity
大体时间：Baseline (immediately post-debonding, before clean-up), 24 hours, and 7 days post-adhesive removal.
|
Patient-reported pain and hypersensitivity evaluated using a Visual Analogue Scale (VAS) score ranging from 0 (No pain) to 10 (Unbearable severe pain) in response to a 2-second dental syringe air-blast stimulus test. |
Baseline (immediately post-debonding, before clean-up), 24 hours, and 7 days post-adhesive removal.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Procedure Time
大体时间：Immediately during the clean-up procedure.
|
Time taken to perform complete residual adhesive removal per tooth, measured using a stopwatch |
Immediately during the clean-up procedure.
|
合作者和调查者
调查人员
- 研究主任：Heba El-Deeb, PhD、Cairo to Department of Conservative Dentistry, Faculty of Dentistry, Cairo University .
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CONS 3-4-1
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