Dry-Shield vs Rubber Dam During Fissure Sealant Placement (DRY-SEAL)
Efficiency of Using Dry-Shield and Rubber Dam Isolation on Fissure Sealant Application in Permanent Molars: A Randomized Clinical Trial
This randomized clinical trial aims to evaluate the efficiency of the Dry-Shield isolation system compared with rubber dam isolation and cotton roll isolation during fissure sealant application in permanent molars among pediatric patients.
The study evaluates chairside time, patient preference, and fissure sealant retention rates after 6 and 12 months of follow-up. Proper isolation during fissure sealant application is considered essential for optimal retention and long-term clinical success.
The study also aims to assess whether Dry-Shield can provide a practical and comfortable alternative to conventional isolation techniques in pediatric dentistry.
調査の概要
詳細な説明
Fissure sealants are widely used preventive measures for reducing occlusal caries in permanent molars. Successful sealant retention largely depends on adequate moisture control during application. Rubber dam isolation has traditionally been considered the gold standard for moisture control; however, its use in pediatric dentistry may be associated with increased chair time and patient discomfort.
Dry-Shield is an isolation device that combines suction, tongue retraction, bite block support, and moisture control in a single system. This may improve clinical efficiency and patient comfort during dental procedures.
This randomized clinical trial compares the Dry-Shield isolation system with rubber dam isolation and cotton roll isolation during fissure sealant application in permanent molars in children. The study evaluates clinical efficiency through assessment of chairside time, patient preference, and fissure sealant retention at 6 and 12month follow-ups.
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
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Ismailia Governorate
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Ismailia、Ismailia Governorate、エジプト、41522
- Faculty of Dentistry, Suez Canal University
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参加基準
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:
A- Patient inclusion criteria:
- Cooperative, apparently healthy children.
- Each child had at least three fully erupted first and/or second permanent molars.
- Patient being at high risk of dental caries.
- Informed consent was filled before treatment.
B- Molar inclusion criteria:
- Tooth had deep pits and fissures.
- Molars with the International Caries Detection and Assessment System (ICDAS) score 0-2.
- All three molars required PFS.
Exclusion Criteria:
A- Patient exclusion criteria:
- Uncooperative children.
- Children with special needs.
- Children who required emergency dental care (draining sinus, abscess and cellulitis).
- Who were suffering from an allergy to latex or a severe gag reflex.
- Mouth breather or child with nasal obstruction.
- Children with fixed orthodontic.
B- Molar exclusion criteria:
- Previous restored or carious first or second permanent molars.
- Molars with anomalies of the enamel or dentin.
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：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Group 1: Dry-Shield Isolation
Participants receive pit and fissure sealant using Dry-Shield isolation system in a split-mouth design.
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Application of a fluoride-releasing, resin-based pit and fissure sealant (Conseal F) on eligible permanent molars to evaluate and compare the clinical efficiency of three different isolation methods.
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アクティブコンパレータ：Group 2: Rubber Dam Isolation
Participants receive pit and fissure sealant using rubber dam isolation technique in a split-mouth design.
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Application of a fluoride-releasing, resin-based pit and fissure sealant (Conseal F) on eligible permanent molars to evaluate and compare the clinical efficiency of three different isolation methods.
|
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アクティブコンパレータ：Group 3: Cotton Roll Isolation
Participants receive pit and fissure sealant using cotton roll isolation technique in a split-mouth design
|
Application of a fluoride-releasing, resin-based pit and fissure sealant (Conseal F) on eligible permanent molars to evaluate and compare the clinical efficiency of three different isolation methods.
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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
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sealant Retention Rate
時間枠：6 months and 12 months
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Evaluation of fissure sealant retention using Simonsen criteria after 6 and 12 months.
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6 months and 12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Chairside Time
時間枠：Immediately during procedure
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Assessment of the time required for fissure sealant application using each isolation technique
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Immediately during procedure
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Patient Preference and discomfort
時間枠：Immediately after procedure
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Assessment of patient preference and discomfort using a questionnaire and Wong-Baker FACES pain rating scale after fissure sealant placement
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Immediately after procedure
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- SCU-PEDO-RCT-2025
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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