Comparison of the Efficacy of Inferior Alveolar Nerve Block and Digital Anesthesia in Pulpectomy of Mandibular Permanent Molars in Children
This study aims to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in achieving adequate anesthesia in pediatric patients presenting with acute dental pain and requiring emergency endodontic treatment of mandibular permanent molars. Achieving profound anesthesia in such cases can be challenging due to acute inflammation.
Participants will be randomly assigned to receive either conventional IANB or digital anesthesia. Pain perception during the procedure will be assessed using validated pain scales. In addition, physiological parameters including heart rate and blood pressure will be recorded to evaluate the stress response associated with each anesthesia technique. Anesthesia success will be determined based on the absence of pain during treatment and the need for supplemental anesthesia.
The findings of this study are expected to provide evidence-based guidance for selecting the most effective and comfortable anesthesia technique in pediatric dental patients.
調査の概要
状態
詳細な説明
Achieving effective local anesthesia in pediatric patients presenting with acute dental pain remains a significant clinical challenge, particularly in mandibular permanent molars requiring emergency endodontic treatment. The success of conventional inferior alveolar nerve block (IANB) may be reduced in the presence of acute inflammation, leading to inadequate pain control and increased patient anxiety.
Computer-controlled digital anesthesia systems have been introduced as an alternative technique that allows for a more controlled and consistent delivery of local anesthetic solution. This may improve both patient comfort and the success of anesthesia.
The aim of this randomized clinical study is to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in pediatric patients with acute dental pain requiring emergency endodontic treatment of mandibular permanent molars.
Participants will be randomly allocated into two groups: the IANB group and the digital anesthesia group. All procedures will be performed under standardized clinical conditions. Pain perception during anesthesia administration and treatment will be evaluated using validated pain assessment scales.
In addition to subjective pain evaluation, physiological parameters including heart rate and blood pressure will be recorded to assess the stress response associated with each anesthesia technique. Anesthesia success will be determined based on the absence of pain during treatment and the need for supplemental anesthesia.
The results of this study are expected to provide clinically relevant evidence regarding the most effective and comfortable anesthesia technique for pediatric patients, thereby improving treatment outcomes and patient experience.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Nisanur Müdüroğlu, DDS
- 電話番号:905434631893
- メール:nsnr_mdr@hotmail.com
研究連絡先のバックアップ
- 名前:Merve Bilmez Selen, PhD
- 電話番号:905457673098
研究場所
-
-
Malatya
-
Malatya、Malatya、トルコ(Türkiye)、44280
- 募集
- Inonu University Faculty of Dentistry
-
コンタクト:
- nisanur müdüroğlu
- 電話番号:905434631893
- メール:nisanur.muduroglu@inonu.edu.tr
-
-
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 6-14 years
- Patients presenting with acute dental pain
- Patients requiring emergency endodontic treatment in mandibular permanent molars
- Cooperative patients who allowed clinical procedures
- Patients whose parents/legal guardians provided informed consent
Exclusion Criteria:
- Patients with systemic diseases affecting pain perception
- Patients with known allergy to local anesthetic agents
- Patients who used analgesics within 12 hours before treatment
- Patients with non-restorable teeth
- Patients with a history of behavioral management problems preventing treatment
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: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:Inferior Alveolar Nerve Block Group
Participants receiving conventional inferior alveolar nerve block anesthesia for mandibular permanent molars requiring emergency endodontic treatment.
|
Participants requiring emergency endodontic treatment for mandibular permanent molars will receive computer-controlled intraosseous digital anesthesia using the SleeperOne computer-controlled local anesthesia delivery system and 4% articaine hydrochloride with 1:100,000 epinephrine.
|
|
実験的:Digital Anesthesia Group
Participants receiving computer-controlled digital anesthesia for mandibular permanent molars requiring emergency endodontic treatment.
|
Participants requiring emergency endodontic treatment for mandibular permanent molars will receive conventional inferior alveolar nerve block anesthesia using a conventional dental syringe and 4% articaine hydrochloride with 1:100,000 epinephrine.
|
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 |
|---|---|---|
|
Anesthesia success during endodontic treatment
時間枠:During the procedure
|
Anesthetic success will be defined as completion of endodontic treatment without the need for supplemental anesthesia.
Pain during treatment will be assessed using the Visual Analog Scale (VAS; 0-10) and will be considered in the evaluation of anesthetic success.
Higher VAS scores indicate greater pain perception and lower anesthetic success.
|
During the procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Heart rate changes
時間枠:Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
|
Heart rate will be recorded at predefined time points to evaluate physiological stress response during anesthesia administration and treatment.
|
Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood pressure changes
時間枠:Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
|
Blood pressure will be measured at predefined time points to assess the physiological stress response associated with the anesthesia techniques.
|
Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
|
協力者と研究者
スポンサー
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 (実際)
一次修了 (推定)
研究の完了 (推定)
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
その他の研究ID番号
- 2025/8393
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?
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。