Pain and Anxiety During Vital Pulp Therapy Using Different Local Anesthesia Techniques in Children
2026年7月31日 更新者：DİLARA NİL GÜNAÇAR、Recep Tayyip Erdogan University Training and Research Hospital
Evaluation of the Effects of Different Local Anesthesia Techniques on Dental Anxiety and Pain During Vital Pulp Therapy
This prospective observational study aims to evaluate the effects of different local anesthesia techniques on dental anxiety and pain in children undergoing vital pulp therapy of permanent mandibular first molars.
Conventional inferior alveolar nerve block and two computer-controlled local anesthetic delivery (CCLAD) systems used in routine clinical practice will be compared.
The choice of anesthesia technique will be based on the clinician's routine decision-making, and no additional intervention or modification of standard treatment will be performed for research purposes.
Dental anxiety, pain, physiological parameters, and postoperative complications will be assessed using validated clinical scales and routine clinical measurements.
The findings may help improve pain and anxiety management during pediatric dental treatment while supporting evidence-based selection of local anesthesia techniques.
調査の概要
研究の種類
観察的
入学 (推定)
120
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
サンプリング方法
非確率サンプル
調査対象母集団
The study population will consist of children aged 8-10 years who require vital pulp therapy of permanent mandibular first molars and attend the Department of Pediatric Dentistry at Recep Tayyip Erdoğan University Faculty of Dentistry.
Eligible participants will be systemically healthy children with appropriate cognitive and communication abilities and acceptable cooperation levels according to the Frankl Behavior Rating Scale (scores 3 or 4).
Participants will be evaluated according to the routine clinical care provided, and the effects of different local anesthesia techniques on dental anxiety, pain response, physiological parameters, and postoperative outcomes will be assessed.
説明
Inclusion Criteria:
- Children aged 8-10 years.
- Children and parents/legal guardians who agree to participate in the study and provide informed consent.
- Patients requiring vital pulp therapy of a permanent mandibular first molar.
- Patients classified as Frankl Behavior Rating Scale score 3 or 4. Systemically healthy children (ASA I).
- Children with adequate cognitive and communication abilities to understand the study procedures and pain/anxiety assessment scales.
- Permanent mandibular first molars without clinical or radiographic signs of abscess, fistula, or periapical pathology.
Exclusion Criteria:
- Children with systemic diseases or medical conditions affecting dental treatment.
- Children classified as Frankl Behavior Rating Scale score 1 or 2.
- Patients with known allergy or hypersensitivity to local anesthetic agents (e.g., lidocaine, articaine).
- Teeth with acute dental infection signs, including abscess, cellulitis, or extensive infection.
- Teeth showing clinical or radiographic evidence of periapical pathology.
- Children unable to understand or complete pain and anxiety assessment scales due to cognitive, visual, hearing, or communication limitations.
- Patients who do not comply with the study procedures or withdraw consent.
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
コホートと介入
グループ/コホート |
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Conventional Inferior Alveolar Nerve Block
Participants in this cohort receive conventional inferior alveolar nerve block anesthesia as part of routine clinical care before vital pulp therapy of permanent mandibular first molars.
The anesthesia technique is selected by the treating clinician according to standard clinical practice.
No additional intervention or modification of the anesthesia procedure is performed for study purposes.
Pain, dental anxiety, physiological parameters, and postoperative outcomes are evaluated and recorded.
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QuickSleeper Computer-Controlled Local Anesthesia
Participants in this cohort receive computer-controlled local anesthetic delivery using the QuickSleeper system as part of routine clinical care before vital pulp therapy of permanent mandibular first molars.
The anesthesia technique is selected by the treating clinician according to standard clinical practice.
No additional intervention or modification of the routine treatment protocol is performed for study purposes.
Pain, dental anxiety, physiological parameters, and postoperative outcomes are evaluated and recorded.
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Controlled Local Anesthetic Delivery System Group
Participants in this cohort receive computer-controlled local anesthetic delivery using the SOAN system as part of routine clinical care before vital pulp therapy of permanent mandibular first molars.
The SOAN system allows controlled administration of local anesthetic solution with regulated flow and pressure during the injection procedure.
The anesthesia technique is selected by the treating clinician according to standard clinical practice and clinical requirements.
No additional intervention, modification of the routine treatment protocol, or procedure solely for research purposes is performed.
Dental anxiety, pain responses, physiological parameters, and postoperative outcomes are evaluated and recorded during and after the routine dental treatment process.
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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 Response During Local Anesthesia Administration
時間枠：During local anesthesia administration
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Pain response during local anesthesia administration will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale.
The FLACC scale evaluates behavioral pain responses in children based on five domains: facial expression, leg movement, activity, crying, and consolability.
Scores range from 0 to 10, with higher scores indicating greater pain intensity.
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During local anesthesia 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 Level Assessed by the Modified Child Dental Anxiety Scale-Faces Version (MCDASf)
時間枠：Baseline (before treatment) and immediately after completion of treatment
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Dental anxiety levels will be evaluated using the Modified Child Dental Anxiety Scale-Faces version (MCDASf).
The scale includes eight dental situations rated on a five-point Likert scale ranging from 1 (relaxed/not anxious) to 5 (very anxious).
Total scores range from 8 to 40, with higher scores indicating higher levels of dental anxiety.
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Baseline (before treatment) and immediately after completion of treatment
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Immediate Emotional Status Assessed by the Facial Image Scale (FIS)
時間枠：Before anesthesia administration and after local anesthesia administration
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The Facial Image Scale (FIS) will be used to evaluate children's immediate emotional status and dental anxiety.
The scale consists of five facial expressions ranging from very happy to very unhappy.
Higher scores indicate increased anxiety levels.
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Before anesthesia administration and after local anesthesia administration
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Post-Treatment Pain Intensity Assessed by the Wong-Baker Faces Pain Rating Scale
時間枠：Immediately after completion of treatment
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Pain intensity after completion of vital pulp therapy will be assessed using the Wong-Baker Faces Pain Rating Scale.
The scale ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain intensity.
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Immediately after completion of treatment
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Heart Rate
時間枠：Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
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Heart rate (beats per minute) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.
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Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
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Postoperative Complications After Vital Pulp Therapy
時間枠：24 hours after treatment
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Postoperative complications following vital pulp therapy will be assessed by contacting parents 24 hours after treatment.
The presence or absence of postoperative symptoms will be recorded.
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24 hours after treatment
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Blood Pressure
時間枠：Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
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Systolic and diastolic blood pressure (mmHg) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.
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Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
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Peripheral Oxygen Saturation (SpO₂)
時間枠：Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
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Peripheral oxygen saturation (%) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.
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Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
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Body Temperature
時間枠：Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
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Body temperature (°C) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.
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Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
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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 (推定)
2026年8月1日
一次修了 (推定)
2026年11月15日
研究の完了 (推定)
2026年12月30日
試験登録日
最初に提出
2026年7月28日
QC基準を満たした最初の提出物
2026年7月31日
最初の投稿 (実際)
2026年8月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月5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31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
その他の研究ID番号
- 2026/319
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
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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