3D-Printed Resin Crowns vs Stainless Steel Crowns in Pulpotomized Primary Molars. (3DRSCVSSSC)
Clinical Evaluation of 3D Printed Resin Based Crowns Versus Stainless Steel Crowns in Pulpotomized Primary Mandibular Molars : A Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn whether 3D-printed resin-based crowns are an effective alternative to stainless steel crowns for restoring pulpotomized primary mandibular molars in children. The main questions it aims to answer are:
Do 3D-printed resin-based crowns provide better gingival health than stainless steel crowns? Are there differences in plaque accumulation, crown retention, and child and parent satisfaction between the two crown types?
Participants will:
Receive either a 3D-printed resin-based crown or a stainless steel crown after pulpotomy.
Attend follow-up visits for clinical evaluation over 12 months.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前:Nariman Osama, BDS
- 電話番号:01010381531
- メール:Nareman.osama@dentistry.cu.edu.eg
研究場所
-
-
-
Cairo、エジプト
- Faculty of Dentistry
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Children aged 4 to 8 years. Cooperative children who are able to accept dental treatment. Teeth diagnosed with reversible pulpitis. Children in good general health with no systemic conditions affecting oral health.
Parents/guardians willing to provide written informed consent and attend follow-up visits.
Exclusion Criteria:
Teeth deemed non-restorable (e.g., gross carious destruction or fractures beyond restoration).
Parents/guardians unwilling to participate in the study or provide informed consent.
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
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的:3D printed resin crowns
Children will receive indirect restorations using 3D-printed resin crowns on primary molars affected by reversible pulpitis
|
1-Select an appropriately sized resin-based prefabricated crown based on the mesio-distal width of the tooth.
2-Perform occlusal reduction of approximately 1.5-2.0
mm following the natural occlusal anatomy.
3-Reduce buccal and lingual cusps, central groove, and marginal ridges to achieve adequate occlusal clearance.
4-Perform proximal reduction using a tapered fissure or diamond bur to eliminate mesial and distal contacts by approximately 1.0 mm.
5-Avoid creating ledges or damaging adjacent teeth during proximal reduction.
6-Slightly reduce buccal and lingual surfaces to eliminate undercuts and facilitate crown seating.
7-Round and smooth all sharp line angles and points of the preparation.
8-In cases with adjacent teeth, perform additional interproximal reduction if required for proper seating.9-Try-in the crown intraorally and seat it using firm pressure from lingual to buccal direction.
10-Check marginal adaptation, ensuring slight subgingival extension (approximately 0.5-1.0
mm).
|
|
アクティブコンパレータ:Stainless steel crowns
Children will receive stainless steel crowns on primary molars affected by reversible pulpitis
|
1-Select an appropriately sized stainless steel crown based on the mesiodistal width of the tooth.
2-Perform minimal occlusal reduction (approximately 1.0-1.5 mm) following the anatomical occlusal contour to create suficient space for crown placement.
3-Lightly reduce proximal contacts to allow crown seating, without creating steps or excessive taper.
4-Perform minimal buccal and lingual reduction only if required to eliminate undercuts and facilitate passive seating.
5-Round sharp line angles and smooth rough surfaces to allow proper adaptation.
5-Verify adequate occlusal clearance and passive path of insertion.
6-Try-in the crown and adjustsize if necessary to ensure proper fit.
7-Trim and contour crown margins to achieve optimal gingival adaptation (if needed).
8-Seat the crown firmly using finger pressure to confirm complete seating.
9-Cement the crown with glass ionomer cement and remove excess cement after initial setting.
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この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gingival index
時間枠:baseline, 3 months, 6 months, 9 months, 12 months
|
The GI was measured by passing an explorer tip gently within the sulcus mesial, distal, buccal, and lingual surface of each crowned molar. it was scored on a scale of 0 to 3 0= no bleeding
|
baseline, 3 months, 6 months, 9 months, 12 months
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Plaque accumulation
時間枠:baseline, 3 months, 6 months, 9 months, 12 months
|
Silness &Löe plaque index 0: no plaque.
1: film at gingival margin.
2: moderate accumulation.
3: abundance of plaque.
|
baseline, 3 months, 6 months, 9 months, 12 months
|
|
Child and parent satisfaction
時間枠:Immediately post operative
|
Child and parent satisfaction will be assessed using a structured questionnaire based on a Likert scale.
Participants (children and their parents/guardians) will rate their satisfaction with the treatment experience, comfort, aesthetics, and overall acceptance.
Responses will be recorded on a 5-point Likert scale ranging from "very dissatisfied" to "very satisfied."
The scores will be analyzed to compare satisfaction between study groups.
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Immediately post operative
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Crown retention
時間枠:baseline, 3 months, 6 months, 9 months, 12 months
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Using United States Public Health Service (USPHS) criteria Alpha : intact Bravo : chipped or loss of material Charlie : complete loss of crown
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baseline, 3 months, 6 months, 9 months, 12 months
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協力者と研究者
捜査官
捜査官
- スタディチェア:Sherine Badr, PHD、Cairo University
- 主任研究者:Nariman Osama, BDS、Cairo University
- スタディディレクター:Hanna Abdel Moneim, PHD、Cairo University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- FDCU-2026-01
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
米国で製造され、米国から輸出された製品。
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