Effect of Local Anesthesia Techniques on Pulp Hemostasis in Primary Molars
2026年9月10日 更新者：Ayça Hande Sari、Afyonkarahisar Health Sciences University
Effect of Mandibular Anesthesia and Computer-Controlled Local Anesthesia on Pulp Hemostasis Time During Pulpotomy Treatment of Mandibular Primary Molars: A Split-Mouth Study
The goal of this clinical trial is to compare the effects of two local anesthesia techniques on pulp hemostasis time during pulpotomy treatment of mandibular primary molars in children aged 6-9 years.
The main questions it aims to answer are:
Does the local anesthesia technique affect the time required to achieve pulp hemostasis during pulpotomy? Are there differences between the two anesthesia techniques in terms of pain, heart rate, and oxygen saturation during treatment?
Researchers will compare conventional inferior alveolar nerve block anesthesia with computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system to determine whether the anesthesia technique affects pulp hemostasis time and the secondary clinical outcomes.
Each participant will receive both anesthesia techniques in a randomized order using a split-mouth design. Participants will:
Receive conventional inferior alveolar nerve block anesthesia for pulpotomy treatment of one mandibular primary molar.
Receive computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system for pulpotomy treatment of the contralateral mandibular primary molar at a separate treatment session.
Have pulp hemostasis time recorded during each pulpotomy procedure. Have pain, heart rate, and oxygen saturation assessed during the treatment procedures.
調査の概要
状態
募集
条件
研究の種類
介入
入学 (推定)
40
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：Ayça Hande Sari
- 電話番号：+905065143594
- メール：aycahande94@gmail.com
研究場所
-
-
Afyonkarahisar
-
Afyonkarahisar、Afyonkarahisar、トルコ（Türkiye）、03030
- 募集
- Afyonkarahisar Health Sciences University, Faculty of Dentistry
-
コンタクト：
- Ayça Hande Sari
- 電話番号：+905065143594
- メール：aycahande94@gmail.com
-
-
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
はい
説明
Inclusion Criteria:
- Children aged 6-9 years.
- Presence of a pulpotomy indication in both mandibular primary second molars (teeth 75 and 85).
- Systemically healthy children classified as ASA physical status I or II.
- No known coagulation disorders.
- No use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
- Sufficient cooperation and compliance to allow completion of the planned clinical procedures.
- Written informed consent obtained from a parent or legal guardian for participation in the study.
- No history of a serious adverse reaction or complication associated with either of the local anesthesia techniques used in the study.
Exclusion Criteria:
- Children with systemic health conditions classified as ASA physical status III or higher.
- Known allergy or hypersensitivity to the local anesthetic agents or other dental materials used in the study.
- Presence of a known coagulation disorder or use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
- Presence of severe infection, pulp necrosis, advanced root resorption, or any other dental condition requiring a treatment approach other than pulpotomy in the mandibular primary second molars.
- Insufficient cooperation or behavioral difficulties that would prevent completion of the planned clinical procedures.
- History of a serious adverse reaction or complication associated with either of the local anesthesia techniques used in the study.
- Inability to comply with the study protocol or attend the scheduled study visits.
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：他の
- 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 |
|---|---|
|
実験的：IANB Followed by Intraosseous Anesthesia
Participants allocated to this sequence will receive conventional inferior alveolar nerve block (IANB) anesthesia for pulpotomy treatment of one mandibular primary molar at the first treatment session.
At the second treatment session, computer-controlled intraosseous anesthesia will be administered for pulpotomy treatment of the contralateral mandibular primary molar.
The time required to achieve pulp hemostasis will be recorded during both treatment sessions.
|
Conventional inferior alveolar nerve block anesthesia will be administered before pulpotomy treatment of the mandibular primary molar using a standard dental syringe and an articaine-based local anesthetic solution (Ultracain D-S Forte).
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue.
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) and an articaine-based local anesthetic solution (Ultracain D-S Forte) before pulpotomy treatment of the mandibular primary molar.
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue
|
|
実験的：Intraosseous Anesthesia Followed by IANB
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) before pulpotomy treatment of the mandibular primary molar.
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol, and the time required to achieve pulp hemostasis will be recorded.
|
Conventional inferior alveolar nerve block anesthesia will be administered before pulpotomy treatment of the mandibular primary molar using a standard dental syringe and an articaine-based local anesthetic solution (Ultracain D-S Forte).
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue.
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) and an articaine-based local anesthetic solution (Ultracain D-S Forte) before pulpotomy treatment of the mandibular primary molar.
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue
|
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 |
|---|---|---|
|
Pulp Hemostasis Time
時間枠：During pulpotomy, up to 5 minutes after coronal pulp removal
|
The time required to achieve pulp hemostasis following removal of the coronal pulp tissue during pulpotomy will be recorded for each treatment session.
Hemostasis will be assessed using standardized sterile cotton pellets and categorized according to the time required to achieve bleeding control: ≤2 minutes, >2 to 5 minutes, or failure to achieve hemostasis within 5 minutes.
|
During pulpotomy, up to 5 minutes after coronal pulp removal
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Peripheral Oxygen Saturation (SpO₂)
時間枠：Immediately before local anesthesia administration
|
Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as a percentage (%) to evaluate physiological changes associated with the anesthesia and pulpotomy procedures.
|
Immediately before local anesthesia administration
|
|
Pain Intensity
時間枠：Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit
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Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale.
Participants will select the face that best represents their perceived pain.
The scale ranges from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain intensity.
Pain will be assessed after administration of local anesthesia and after completion of the pulpotomy procedure.
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Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit
|
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Heart Rate
時間枠：Immediately before local anesthesia administration and immediately after local anesthesia administration, during each treatment visit
|
Heart rate will be measured using a pulse oximeter and recorded as beats per minute (bpm) to evaluate physiological changes associated with the anesthesia and pulpotomy procedures.
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Immediately before local anesthesia administration and immediately after local anesthesia administration, during each 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。
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15日
一次修了 (推定)
2027年2月1日
研究の完了 (推定)
2027年2月26日
試験登録日
最初に提出
2026年9月3日
QC基準を満たした最初の提出物
2026年9月3日
最初の投稿 (実際)
2026年9月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月14日
QC基準を満たした最後の更新が送信されました
2026年9月10日
最終確認日
2026年9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
- 26.GENEL.013
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 made publicly available due to participant confidentiality and privacy considerations.
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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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