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Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars (DIA-MIH)

2026年7月26日 更新者：Alp Abidin Ateşçi、Ege University

Digital Intraosseous Anesthesia in MIH-Affected Permanent Molars: A Randomized Clinical Trial

This multicentre, randomized clinical trial compared digital intraosseous anaesthesia with conventional local anaesthetic techniques in children aged 6-12 years receiving restorative treatment for MIH-affected permanent first molars. Within the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia; within the mandibular stratum, it was compared with inferior alveolar nerve block. The primary outcome was child-reported pain during restorative treatment. Secondary outcomes included pain during needle penetration and anaesthetic solution delivery, observed pain-related behaviour, and change in dental anxiety.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Children with an MIH-affected permanent first molar requiring restorative treatment were randomized separately within the maxillary and mandibular strata. In the maxillary stratum, digital intraosseous anaesthesia was compared with conventional infiltration anaesthesia. In the mandibular stratum, digital intraosseous anaesthesia was compared with conventional inferior alveolar nerve block. Only one MIH-affected permanent first molar was included for each child.

Pain during needle penetration, anaesthetic solution delivery, and restorative treatment was assessed using the Wong-Baker FACES Pain Rating Scale. Pain-related behavioural responses were assessed using the Face, Legs, Activity, Cry, Consolability scale, and dental anxiety was assessed before and after local anaesthetic administration using the Modified Child Dental Anxiety Scale.

研究の種類

介入

入学 (実際)

110

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • トルコ（Türkiye）
      • Istanbul、トルコ（Türkiye）
        • Istanbul Beykent University
      • Izmir、トルコ（Türkiye）、35110
        • Ege university

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

説明

Inclusion Criteria:

  • Children aged 6-12 years.
  • Confirmed diagnosis of molar-incisor hypomineralisation according to the European Academy of Paediatric Dentistry diagnostic criteria.
  • Presence of an MIH-affected permanent first molar classified as Würzburg Category 1 or 2a and requiring either a direct resin composite restoration or a stainless steel crown.
  • Positive or definitely positive behaviour according to the Frankl Behaviour Rating Scale.
  • No known allergy to local anaesthetics.
  • No relevant systemic disease.

Exclusion Criteria:

  • Receipt of analgesic, anxiolytic, or sedative medication within 48 hours before the treatment appointment.
  • Previous experience with intraosseous anaesthesia.
  • Presence of an acute dentoalveolar infection at the planned treatment site.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • 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
実験的：Maxillary Digital Intraosseous Anaesthesia Group
Children in this arm received computer-controlled digital intraosseous anaesthesia using the SleeperOne 5 system before restorative treatment of one MIH-affected permanent first molar in the maxillary arch.
デバイス：SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System
Digital intraosseous anaesthesia was administered using the SleeperOne 5 computer-controlled system (Dental Hi Tec, Cholet, France). Initial mucosal anaesthesia was achieved using 0.1-0.2 mL of 4% articaine with 1:200,000 epinephrine, followed by intraosseous administration of an additional 1 mL of the same anaesthetic solution at the device-controlled slow flow rate.
アクティブコンパレータ：Conventional Maxillary Infiltration Anaesthesia Group
Children in this arm received conventional supraperiosteal infiltration anaesthesia in the buccal sulcus adjacent to one MIH-affected maxillary permanent first molar before restorative treatment.
手順：Conventional Maxillary Infiltration Anaesthesia
Supraperiosteal infiltration anaesthesia was performed using a standard aspirating dental syringe and a 27-gauge short needle. One millilitre of 4% articaine with 1:200,000 epinephrine was deposited slowly into the buccal sulcus adjacent to the MIH-affected maxillary permanent first molar.
アクティブコンパレータ：Conventional Mandibular Inferior Alveolar Nerve Block Group
Children in this arm received conventional inferior alveolar nerve block anaesthesia before restorative treatment of one MIH-affected mandibular permanent first molar.
手順：Conventional Inferior Alveolar Nerve Block Anaesthesia
Inferior alveolar nerve block anaesthesia was administered using a standard aspirating dental syringe and a 27-gauge long needle. One millilitre of 4% articaine with 1:200,000 epinephrine was deposited slowly. Adequate anaesthesia was confirmed by patient-reported lip numbness before restorative treatment was started.
実験的：Mandibular Digital Intraosseous Anesthesia Group
Children in this arm received computer-controlled digital intraosseous anaesthesia using the SleeperOne 5 system before restorative treatment of one MIH-affected permanent first molar in the mandibular arch.
デバイス：SleeperOne 5 Computer-Controlled Intraosseous Anaesthesia System
Digital intraosseous anaesthesia was administered using the SleeperOne 5 computer-controlled system (Dental Hi Tec, Cholet, France). Initial mucosal anaesthesia was achieved using 0.1-0.2 mL of 4% articaine with 1:200,000 epinephrine, followed by intraosseous administration of an additional 1 mL of the same anaesthetic solution at the device-controlled slow flow rate.

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
Child-Reported Pain During Dental Treatment Assessed Using the Wong-Baker FACES Pain Rating Scale
時間枠：During the restorative procedure after local anesthesia administration, within the single treatment visit
Children rated the pain experienced during the restorative procedure using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
During the restorative procedure after local anesthesia administration, within the single treatment visit

二次結果の測定

結果測定
メジャーの説明
時間枠
Child-Reported Pain During Needle Penetration Assessed Using the Wong-Baker FACES Pain Rating Scale
時間枠：At the time of needle insertion into the oral mucosa, immediately before delivery of the local anaesthetic solution, during the single treatment visit
Children rated the pain experienced during needle penetration using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
At the time of needle insertion into the oral mucosa, immediately before delivery of the local anaesthetic solution, during the single treatment visit
Child-Reported Pain During Local Anaesthetic Solution Delivery Assessed Using the Wong-Baker FACES Pain Rating Scale
時間枠：During delivery of the local anaesthetic solution, immediately after needle penetration, during the single treatment visit
Children rated the pain experienced during delivery of the local anaesthetic solution using the Wong-Baker FACES Pain Rating Scale. The scale comprises six faces scored 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
During delivery of the local anaesthetic solution, immediately after needle penetration, during the single treatment visit
Observer-Rated Pain-Related Behaviour During Local Anaesthetic Administration Assessed Using the FLACC Scale
時間枠：During the local anaesthetic injection sequence, from needle penetration through completion of anaesthetic solution delivery, before commencement of the restorative procedure, during the single treatment visit
Pain-related behaviour was independently assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. Each of the five components is scored from 0 to 2, producing a total score ranging from 0 to 10. A total score of 0 indicates a relaxed and comfortable child, 1-3 indicates mild discomfort, 4-6 indicates moderate pain, and 7-10 indicates severe pain. Higher scores indicate greater pain-related behavioural responses.
During the local anaesthetic injection sequence, from needle penetration through completion of anaesthetic solution delivery, before commencement of the restorative procedure, during the single treatment visit
Change in Dental Anxiety From Before to After Local Anaesthetic Administration Assessed Using the Modified Child Dental Anxiety Scale
時間枠：Immediately before and immediately after local anaesthetic administration, during the single treatment visit
Dental anxiety was assessed using the eight-item Modified Child Dental Anxiety Scale (MCDAS). Each item is scored from 1 (relaxed) to 5 (extremely anxious), producing a total score ranging from 8 to 40. Higher total scores indicate greater dental anxiety. Change was calculated as the post-anaesthesia score minus the pre-anaesthesia score; negative values indicate a reduction in dental anxiety.
Immediately before and immediately after local anaesthetic administration, during the single treatment visit

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ege University

捜査官

  • 主任研究者：Alp Abidin Atesci, PhD、Istanbul Beykent University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年12月20日

一次修了 (実際)

2026年4月15日

研究の完了 (実際)

2026年4月15日

試験登録日

最初に提出

2026年7月26日

QC基準を満たした最初の提出物

2026年7月26日

最初の投稿 (実際)

2026年7月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月30日

QC基準を満たした最後の更新が送信されました

2026年7月26日

最終確認日

2026年7月1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

  • MIH-DIA-RCT-2026
  • 24-11/83 (その他の識別子：Ege University Ethics Committee)

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?

いいえ

IPD プランの説明

Individual participant data will not be shared. Study findings will be reported only in aggregate form to protect participant privacy, as the study involves children and no external IPD-sharing plan was established in the study protocol.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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