Conventional Versus Computer-Assisted Dental Anesthesia
2026年7月24日 更新者：Jose Leonardo Jimenez-Ortiz、University of Montemorelos
Conventional Versus Computer-Assisted Dental Anesthesia: A Pilot Study of a Randomized Clinical Trial
The purpose of this clinical trial was to compare two methods of delivering local dental anesthesia in undergraduate dental students: a computer-controlled local anesthetic delivery (CCLAD) system and a conventional dental syringe. The study evaluated whether the computer-controlled system reduced pain during the administration of local anesthesia compared with the conventional technique.
The main questions this study aimed to answer were:
Does a computer-controlled local anesthetic delivery system reduce pain during maxillary buccal infiltration compared with a conventional dental syringe? Are there differences in physiological responses (blood pressure, heart rate, and oxygen saturation) between the two anesthetic delivery methods? Which anesthetic delivery method do participants prefer after experiencing both techniques? Would participants recommend their preferred anesthetic delivery method to others? Participants attended two study visits approximately one week apart. Each participant received local anesthesia using both delivery methods in a randomized order, serving as his or her own control. Pain, dental anxiety, physiological parameters, anesthetic delivery preferences, and willingness to recommend the preferred method were assessed during the study.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
29
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
-
-
Nuevo León
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Montemorelos、Nuevo León、メキシコ、67530
- University Dental Clinic, Montemorelos University School of Dentistry
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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
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Undergraduate dental student enrolled in the Local Anesthesia course at the Montemorelos University School of Dentistry.
- Aged 18 years or older.
- Able and willing to provide written informed consent.
- Willing to attend both study periods.
Exclusion Criteria:
- Pregnancy or lactation.
- Known allergy or contraindication to lidocaine or epinephrine.
- Systemic conditions contraindicating elective dental treatment.
- Use of medications that could alter cardiovascular responses.
- Medical condition that could interfere with pain perception or study participation.
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：基礎科学
- 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 |
|---|---|
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実験的：Computer-Controlled Local Anesthetic Delivery
Participants received maxillary buccal infiltration anesthesia using a computer-controlled local anesthetic delivery (CCLAD) system during one of two study periods according to the randomized treatment sequence.
Each participant received both study interventions and served as his or her own control.
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Local anesthetic was administered using a computer-controlled local anesthetic delivery (CCLAD) system with 2% lidocaine containing 1:100,000 epinephrine through a 27-gauge short dental needle for maxillary buccal infiltration anesthesia.
The device controlled the flow rate throughout anesthetic administration according to the manufacturer's operating protocol.
他の名前：
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アクティブコンパレータ：Conventional Dental Syringe
Participants received maxillary buccal infiltration anesthesia using a conventional aspirating dental syringe during one of two study periods according to the randomized treatment sequence.
Each participant received both study interventions and served as his or her own control.
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Local anesthetic was administered using a conventional aspirating dental syringe with 2% lidocaine containing 1:100,000 epinephrine through a 27-gauge short dental needle for maxillary buccal infiltration anesthesia.
Anesthetic administration followed the conventional manual injection technique.
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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 local anesthetic administration
時間枠：Immediately after each anesthetic administration
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Pain perceived during maxillary buccal infiltration anesthesia administered with a computer-controlled local anesthetic delivery system or a conventional aspirating dental syringe.
Pain was assessed immediately after each intervention using a 10-cm Visual Analog Scale (VAS), where 0 indicated "no pain" and 10 indicated "worst imaginable pain".
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Immediately after each anesthetic administration
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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 |
|---|---|---|
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Dental anxiety
時間枠：Baseline (before the first study intervention)
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Dental anxiety was assessed using the Modified Dental Anxiety Scale (MDAS; score range: 5-25).
Higher scores indicate greater dental anxiety.
Assessment was performed before the first study intervention.
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Baseline (before the first study intervention)
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Systolic and diastolic blood pressure
時間枠：Before, during, and immediately after each anesthetic administration
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Blood pressure was measured using an automated monitor before, during, and immediately after anesthetic administration.
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Before, during, and immediately after each anesthetic administration
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Heart rate
時間枠：Before, during, and immediately after anesthetic administration
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Heart rate was measured using a pulse oximeter before, during, and immediately after anesthetic administration.
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Before, during, and immediately after anesthetic administration
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Peripheral oxygen saturation (SpO₂)
時間枠：Before, during, and immediately after anesthetic administration
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Peripheral oxygen saturation was measured using a pulse oximeter before, during, and immediately after anesthetic administration.
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Before, during, and immediately after anesthetic administration
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Participant-reported preferred anesthetic delivery method
時間枠：Immediately after completion of the second study intervention
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Participants selected their preferred anesthetic delivery method (computer-controlled local anesthetic delivery system or conventional aspirating dental syringe) after experiencing both interventions.
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Immediately after completion of the second study intervention
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Willingness to recommend the preferred anesthetic delivery method
時間枠：Immediately after completion of the second study intervention
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Willingness to recommend the preferred anesthetic delivery method was assessed using an 11-point Numeric Rating Scale (NRS; 0-10), where 0 indicated "not at all willing to recommend" and 10 indicated "extremely willing to recommend."
Higher scores indicate greater willingness to recommend.
Assessment was performed after completion of the second study intervention.
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Immediately after completion of the second study intervention
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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。
捜査官
- 主任研究者：Jose L Jimenez-Ortiz, DDS、Montemorelos University School of Dentistry
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)
2025年9月2日
一次修了 (実際)
2025年12月2日
研究の完了 (実際)
2025年12月2日
試験登録日
最初に提出
2026年7月20日
QC基準を満たした最初の提出物
2026年7月24日
最初の投稿 (実際)
2026年7月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月28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24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
その他の研究ID番号
- UM-ESEST-2025-015
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?
未定
IPD プランの説明
A final decision regarding the sharing of de-identified individual participant data has not yet been made.
Data sharing will be considered in accordance with institutional policies, participant confidentiality requirements, and applicable ethical and regulatory standards.
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
いいえ
米国FDA規制機器製品の研究
いいえ
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