SleeperOne® 5 Intraosseous Anesthesia in MIH (CCLAD-MIH)
Comparison of SleeperOne® 5-Assisted Intraosseous and Conventional Local Anesthesia for Pain and Anxiety Control in Children With Molar-Incisor Hypomineralization: A Randomized Split-Mouth Clinical Trial
調査の概要
状態
条件
詳細な説明
Molar-incisor hypomineralization (MIH) is a developmental enamel defect that frequently presents with hypersensitivity, post-eruptive enamel breakdown, and an increased risk of restorative treatment failure. Achieving effective local anesthesia in children with MIH can be challenging because hypersensitive teeth often exhibit increased pain during anesthetic administration and restorative procedures. These factors may compromise patient cooperation and the quality of dental treatment.
Computer-controlled local anesthetic delivery systems have been developed to improve injection comfort by controlling the rate and pressure of anesthetic administration. The SleeperOne® 5 system allows computer-controlled intraosseous anesthesia and may provide more effective pain control than conventional local anesthesia during restorative treatment of MIH-affected teeth.
The purpose of this study was to compare SleeperOne® 5-assisted intraosseous anesthesia with conventional local anesthesia in children undergoing restorative treatment of permanent first molars affected by MIH.
The study was conducted as a randomized split-mouth clinical trial in which each participant received both anesthetic techniques during separate treatment sessions. The order of the interventions was determined using computer-generated randomization, allowing each participant to serve as his or her own control. All clinical procedures were performed under standardized conditions by the same operator.
The study was designed to evaluate whether computer-controlled intraosseous anesthesia could improve pain control and patient comfort during restorative treatment of children with MIH compared with conventional local anesthesia.
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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-
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Ankara、トルコ（Türkiye）、06560
- Ankara University Faculty of Dentistry
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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:
- Children aged 8 to 14 years.
- Bilateral symmetrical MIH-affected permanent first molars requiring restorative treatment.
- MIH diagnosed according to EAPD criteria.
- Positive or definitely positive Frankl Behavior Rating Scale.
- Parent or guardian provided written informed consent.
Exclusion Criteria:
- Acute pulpal or periapical pathology.
- Developmental dental anomalies other than MIH.
- Allergy to local anesthetic agents.
- Medical contraindication to local anesthesia.
- Analgesic or anti-inflammatory drug use within 24 hours before treatment.
- Cognitive or communication disorders affecting study assessments.
- Uncooperative behavior.
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：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：SleeperOne® 5-Assisted Intraosseous Anesthesia
Computer-controlled intraosseous anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.
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Computer-controlled intraosseous local anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.
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アクティブコンパレータ：Conventional Local Anesthesia
Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.
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Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.
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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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Pain Perception During Anesthetic Administration
時間枠：Immediately after completion of local anesthesia administration (T1)
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Pain intensity during local anesthetic administration assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Higher scores indicate greater pain intensity.
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Immediately after completion of local anesthesia administration (T1)
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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 |
|---|---|---|
|
Behavioral Pain Response
時間枠：Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure.
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Behavioral pain response assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale.
The FLACC Scale ranges from 0 to 10, with scores of 0 indicating no pain-related behavioral distress and scores of 10 indicating severe pain-related behavioral distress.
Higher scores indicate greater pain-related behavioral distress.
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Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure.
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Dental Anxiety
時間枠：Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
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Dental anxiety assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS).
The CFSS-DS score ranges from 15 to 75, with higher scores indicating greater dental anxiety.
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Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
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Pulse Rate
時間枠：Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).
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Physiological response assessed by pulse rate (beats per minute)
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Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2).
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Peripheral Oxygen Saturation (SpO₂)
時間枠：Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure.
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Physiological response assessed by peripheral oxygen saturation measured by pulse oximetry as a percentage (%).
Higher values indicate greater oxygen saturation.
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Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment 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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 36290600/57/2023
- TDK-2024-3458 (その他の助成金/資金番号：Scientific Research Projects Coordination Unit of Ankara University)
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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