Comparison of Bond Failure Rate of Orthodontic Brackets Bonded With V-Prep and Resin-Modified Glass Ionomer Cement Versus Conventional Acid-Etch Composite Resin
Comparison of Bond Failure Rate of Orthodontic Brackets Bonded With V-Prep and Resin-Modified Glass Ionomer Cement Versus Conventional Acid-Etch Composite Resin: A Split-Mouth Randomized Controlled Trial
Ethical approval will be obtained by the FUSH and informed consent will be obtained from individual patients/guardians in writing. Inclusion and exclusion criteria will be used to obtain random patient samples within the Orthodontic Department of FUCD&H and Baseline parameters like age, gender, O'Leary Plaque Score, malocclusion classification type and degree of overbite will be recorded. Patients will be screened one at a time if they are eligible. For this purpose, sequentially numbered, opaque sealed envelopes will be opened just before the bonding assignment for allocation concealment. Both orally and in writing to all patients. Tooth surfaces will be pumiced and standardized.
While, the Primer light-cured for 10-sec each item, the Control group (enamel) etched for 30-sec, washed for 15-sec and air dried to a frosty white. The tough brackets will be attached, with a baseline underneath, with a thin layer of composite resin pressed down on optimum. Light cured for 10 seconds on mesial and distal surfaces to remove excess adhesive (STEP 7).
Group II (V-Prep): Enamel surface was were in contact with 0%-1.5% diluted Sodium Hypochlorite during 60 seconds, rinsed and thoroughly dried; then the V-Prep was applied. 37% phosphoric acid gel for 30 Sec, rinsed for 15 Sec and dried until a frost white appearance on the etched enamel area. The first is called Primer and will be light cured for 10 seconds. A template will then be provisionally fixed to secure the bottom of the bracket in place with Resin-Modified Glass Ionomer Cement. Clean of excess adhesive, and cure for 10 seconds mesial and distal.
Then instead of going to bonding, this will be taken out and ligated to a 0.012-in Ni-Ti archwire. Will follow a 30 days interval series of 6 follow-up visits, monthly visits throughout 6 months
調査の概要
状態
詳細な説明
Ethical approval will be obtained by the FUSH and informed consent will be obtained from individual patients/guardians in writing. Inclusion and exclusion criteria will be used to obtain random patient samples within the Orthodontic Department of FUCD&H and Baseline parameters like age, gender, O'Leary Plaque Score, malocclusion classification type and degree of overbite will be recorded. Patients will be screened one at a time if they are eligible. For this purpose, sequentially numbered, opaque sealed envelopes will be opened just before the bonding assignment for allocation concealment. Both orally and in writing to all patients. Tooth surfaces will be pumiced and standardized. To minimize inter-operator variability for any of the procedures listed above, all bonding will be completed by a single operator (principal investigator) that has been trained on the trial.
While, the Primer light-cured for 10-sec each item, the Control group (enamel) etched for 30-sec, washed for 15-sec and air dried to a frosty white. The tough brackets will be attached, with a baseline underneath, with a thin layer of composite resin pressed down on optimum. Light cured for 10 seconds on mesial and distal surfaces to remove excess adhesive (STEP 7).
Group II (V-Prep): Enamel surface was were in contact with 0%-1.5% diluted Sodium Hypochlorite during 60 seconds, rinsed and thoroughly dried; then the V-Prep was applied. 37% phosphoric acid gel for 30 Sec, rinsed for 15 Sec and dried until a frost white appearance on the etched enamel area. The first is called Primer and will be light cured for 10 seconds. A template will then be provisionally fixed to secure the bottom of the bracket in place with Resin-Modified Glass Ionomer Cement. Clean of excess adhesive, and cure for 10 seconds mesial and distal Then instead of going to bonding, this will be taken out and ligated to a 0.012-in Ni-Ti archwire. Will follow a 30 days interval series of 6 follow-up visits, monthly visits throughout 6 months
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Punjab Province
-
Rawalpindi、Punjab Province、パキスタン、44000
- Foundation University College of Dentistry and Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients aged 12-18 years
- The extraction was limited to Two arches.
- Functional Overbite/Underbite ( < 50% or 1, 2-3 mm?)
- Malocclusions Class I or II
Exclusion Criteria:
- Class III malocclusion
- Type 2: Facial Osteopathy (Cleft lip or palate)
- The history of allergic reactions to dental materials goes back to 1903.Allergic reactions to dental materials date back to 1903.
- Developmental enamel defects (fluorosis, hypoplasia)
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：単一グループの割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：V-Prep and Resin-Modified Glass Ionomer Cement
V prep with sodium hypochlorite and bonding with RMGIC
|
V-Prep with sodium hypochlorite and bonding with Resin-Modified Glass Ionomer Cement
|
|
アクティブコンパレータ：Conventional Acid-Etch Composite Resin
Conventional Composite Resin Bonding
|
Conventional Composite Resin bonding
|
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 |
|---|---|---|
|
Bond Failure Rate of Orthodontic Brackets
時間枠：6 months
|
Time-to-failure of orthodontic brackets between the V-Prep and Resin-Modified Glass Ionomer Cement [RMGIC] and conventional 37% phosphoric acid-etch composite resin technique.
|
6 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
- FUCD-Ortho- 26
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?
IPD プランの説明
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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