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小児におけるデジタル骨内麻酔と手動歯根膜麻酔の比較

2026年11月3日 更新者:Funda Cagırır Dindaroglu、Izmir Katip Celebi University

小児におけるデジタル骨内麻酔と手動歯根膜麻酔の比較:無作為化比較試験

The aim of this study is to compare the effects of digital intraosseous anesthesia and manual intraligamentary anesthesia techniques on pain scores during the restorative treatment of permanent mandibular molars in pediatric patients. In addition, the techniques will be compared in terms of injection pain, anesthetic success, postoperative complications, and patient preferences. This randomized, controlled, crossover, single-blind, split-mouth study will be conducted on 78 children aged 6-12 years. Participants with bilateral permanent mandibular molars presenting enamel-dentin carious lesions will be included in the study.

調査の概要

詳細な説明

Participants who meet the eligibility criteria will be allocated into two study arms according to age, sex, dental experience, DMFT/dmft scores, ICDAS II classification, and radiographic findings. Each participant will receive two different anesthesia techniques-digital intraosseous anesthesia and manual intraligamentary anesthesia-applied to the right and left permanent first mandibular molars with a one-week washout period between visits.

The study population will be divided into two sequence groups. In Group 1 (n = 39), intraligamentary anesthesia will be administered during the first visit, followed by digital intraosseous anesthesia in the second visit. In Group 2 (n = 39), the sequence will be reversed, with digital intraosseous anesthesia administered first and intraligamentary anesthesia administered during the second visit.

Pain perception during both the injection phase and the restorative procedure will be subjectively assessed using the Visual Analog Scale (VAS) and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate and arterial oxygen saturation, will be monitored and recorded. Anesthetic quality and success will be evaluated at the end of each visit based on the clinical outcomes of the restorative procedure.

Following each anesthesia administration, participants will be informed of potential complications, including allergic reactions, a sensation of tooth elevation, or postoperative sensitivity related to the restoration. They will be instructed to document any complications encountered. Postoperative complications will be collected by contacting participants one day after both the first and second visits. At the end of the second visit, each participant's preferred anesthesia technique will also be recorded.

研究の種類

介入

入学 (推定)

78

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。

研究連絡先

  • 名前:Funda Çağırır Dindaroğlu, Study Director
  • 電話番号:+905363465653
  • メール:fundacagirir@gmail.com

研究連絡先のバックアップ

  • 名前:Buse Düzgün, Principal Investigator
  • 電話番号:+905073022366
  • メール:busedzgn@hotmail.com

研究場所

    • Cigli
      • Izmir、Cigli、トルコ(Türkiye)、35000
        • 募集
        • Izmir Katip Çelebi University Faculty of Dentistry
        • コンタクト:

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

6年~12年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Subjects with American Society of Anesthesiologists score I (ASA I)
  • Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),
  • Subjects with indication of similar restoration treatment on bilateral first -permanent mandibular molars
  • Subjects whose plaque index score of 0 (no plaque) and 1
  • Subjects whose gingival index score of 0

Exclusion Criteria:

  • Allergic to the local anesthetics or sulfites
  • Subjects with cholinesterase deficiency
  • Subjects who use drugs that may affect the assessment of pain, such as narcotic or non-narcotic analgesic, anti-inflammatory, anxiolytic, antipsychotic and antihistamine agents
  • Subjects who need to use sedatives or other medications during dental procedures

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: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:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Intraligamentary Anaesthesia

Before the restorative treatment of mandibular first molar, SOPIRA® 30 gauge extra-short cartridge needle attached to the tip of the SOPIRA® Citoject (SOPIRA® Heraeus Kulzer, Hanau, Almanya) pressure injector will be inserted into the periodontal sulcus 1-2 mm until resistance. The needle will be at an angle of 30 degrees to the long axis of the tooth. As recommended by the manufacturer, a total of 0.36 ml (mesiobuccal and distobuccal) 4% articaine solution containing 1:100,000 epinephrine (Ultracaine DS forte cartridge, Sanofi-Aventis GmbH, Almanya) will be injected slowly over 42 seconds by pressing the dosing lever 3 times for each root. If the anaesthesia will be failed, we would use the 4-point IL injection by injecting the mesiolingual sulcus and distolingual sulcus with the same technique.

Anesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection

他の名前:
  • 2点または4点の靭帯内注射
アクティブコンパレータ:Digital Intraosseous Anesthesia

For the digital intraosseous anesthesia technique, the handpiece will be stabilized by holding it as close to the needle as possible and maintaining firm support on the device holder to ensure maximum precision. To enhance the accuracy of movements, stable intraoral finger rests will be used throughout the procedure. The Effitec needle will be positioned at the papillary apex and oriented toward the area between the apices of the two adjacent teeth.

To maintain correct needle positioning and prevent rotational movement, the handpiece will be held nearly parallel to the gingival tissues. Penetration will be directed toward the center of the interdental septum. When the needle enters the cancellous bone, a characteristic sensation similar to cracking an eggshell may be perceived. Before initiating the injection, the needle will be slightly withdrawn to ensure proper placement and avoid excessive penetration.

Anesthesia for one tooth using computer-controlled single-point injection into cancellous bone

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
Pain intensity using Visual Analog Scale (VAS)
時間枠:During injection and during dental procedure

Subjective pain perception measured using a 0-10 Visual Analog Scale (0 = no pain, 10 = worst possible pain). Pain is assessed during injection and during dental treatment.

During injection and during dental procedure
Pain intensity using Wong-Baker FACES Pain Rating Scale
時間枠:During injection and during dental procedure

Subjective pain perception measured using the Wong-Baker FACES Pain Rating Scale (0-10), where higher scores indicate greater pain. Pain is assessed during injection and during dental treatment.

During injection and during dental procedure
Heart rate changes
時間枠:Baseline, during injection and during dental procedure

Heart rate measured using a pulse oximeter (beats per minute, bpm).

Baseline, during injection and during dental procedure
Oxygen saturation (SpO₂) changes
時間枠:Baseline, during injection and during dental procedure

Arterial oxygen saturation measured using a pulse oximeter (%).

Baseline, during injection and during dental procedure
Practitioner's assessment of anesthesia success
時間枠:Immediately after dental treatment

Clinician-reported outcomes including need for additional anesthesia, presence of discomfort during treatment, and successful completion of the procedure without pain.

Immediately after dental treatment
Postoperative complications
時間枠:Day 1 after intervention

Presence of postoperative complications related to local anesthesia.

Day 1 after intervention

二次結果の測定

結果測定
メジャーの説明
時間枠
Correlation between pain scores measured by VAS and Wong-Baker FACES scale
時間枠:Immediately after injection

Correlation between pain scores measured using the Visual Analog Scale (VAS, 0-10) and Wong-Baker FACES Pain Rating Scale (0-10) following local anesthetic injection in children aged 6-12 years. Higher scores indicate greater pain intensity.

Immediately after injection

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。

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)

2026年4月1日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2027年10月1日

試験登録日

最初に提出

2026年3月24日

QC基準を満たした最初の提出物

2026年4月5日

最初の投稿 (実際)

2026年4月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月4日

QC基準を満たした最後の更新が送信されました

2026年11月3日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2025/75

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