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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Asmaa Badr Abdelfatah, BDS
- 電話番号：+20 1148106593
- メール：asmaa.abdelfatah@dentistry.cu.edu.eg
研究連絡先のバックアップ
- 名前：Heba El-Deeb, PhD
- 電話番号：+20 106 610 9461
- メール：heba.eldeeb@dentistry.cu.edu.eg
研究場所
-
-
-
Cairo、エジプト
- Faculty of Dentistry, Cairo University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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. |
|
実験的：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. |
|
実験的：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. |
|
実験的：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Hypersensitivity
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Procedure Time
時間枠：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.
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Heba El-Deeb, PhD、Cairo to Department of Conservative Dentistry, Faculty of Dentistry, Cairo University .
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CONS 3-4-1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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