Buffered Versus Conventional Local Anesthesia for Pain and Anxiety Reduction in School-Aged Children With Pulpitis
Efficacy of Buffered Versus Conventional Local Anesthesia for Reducing Pain and Anxiety During Dental Treatment in School-Aged Children Diagnosed With Pulpitis: A Randomized Controlled Clinical Trial
The objective of this clinical trial is to evaluate whether buffered local anesthesia is more effective than conventional local anesthesia in reducing pain responses in school-aged children requiring dental treatment for pulpitis. The study will also assess differences in physiological and self-reported indicators of pain and anxiety, as well as anesthetic onset and duration.
The main questions it aims to answer are:
Does buffered local anesthesia reduce behavioral pain scores measured by the FLACC scale compared to conventional local anesthesia? Does buffered local anesthesia improve physiological and psychometric indicators of pain and anxiety during dental procedures?
Methodology: The researchers will compare buffered local anesthesia with conventional local anesthesia during routine dental treatment procedures such as pulpotomy or pulpectomy in primary molars.
Participants will:
Receive either buffered or conventional local anesthesia during dental treatment Undergo pulpotomy or pulpectomy depending on clinical diagnosis Be monitored for pain and anxiety using FLACC scale, heart rate, skin conductance, and Wong-Baker Faces Pain Scale at different stages of treatment Have the onset and duration of anesthesia recorded during and after the procedure Be followed until recovery of soft tissue sensation after treatment
調査の概要
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：Mayte A Condori Chambi, Cirujano Dentista
- 電話番号：+524446641295
- メール：maytecondori97@gmail.com
研究場所
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San Luis Potosí
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San Luis Potosí City、San Luis Potosí、メキシコ、78290
- 募集
- Universidad Autónoma de San Luis Potosí
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コンタクト：
- Mayte A Condori Chambi, Cirujano Dentista
- 電話番号：4446641295
- メール：maytecondori97@gmail.com
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-
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 to 12 years
- Diagnosis of irreversible pulpitis due to dental caries in primary maxillary molars
- American Society of Anesthesiologists (ASA) Physical Status Classification I
- Cooperative or definitely cooperative behavior according to Frankl Behavioral Scale (Frankl III or IV)
- Written informed consent provided by parent or legal guardian, and child assent when applicable
- No use of analgesic or anti-inflammatory medication within 24 hours prior to the procedure
Exclusion Criteria:
- Known allergy to any component of local anesthetic solution
- History of negative or traumatic dental experiences within the previous 12 months that may interfere with behavioral assessment
- Radiographic evidence of periapical pathology associated with the affected tooth
- Presence of localized abscess or acute spreading infection at the injection site
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：4倍
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：Buffered Local Anesthesia
Participants will receive buffered local anesthesia during dental treatment for pulpitis.
The local anesthetic solution will consist of lidocaine with epinephrine combined with sodium bicarbonate to increase pH prior to administration.
The intervention will be applied via local infiltration or nerve block as clinically indicated for pulpotomy or pulpectomy procedures in primary maxillary molars
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Local anesthetic solution buffered with sodium bicarbonate prior to administration in order to increase pH and potentially improve onset and patient comfort during dental procedures.
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アクティブコンパレータ：Conventional Local Anesthesia
Participants will receive conventional local anesthesia during dental treatment for pulpitis.
The anesthetic solution will consist of lidocaine with epinephrine administered without buffering.
The intervention will be applied via local infiltration or nerve block according to clinical indication for pulpotomy or pulpectomy procedures in primary maxillary molars.
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Standard commercially available local anesthetic solution used in routine dental practice without pH modification
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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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FLACC PAIN SCORE
時間枠：Baseline (before local anesthetic administration), during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
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Pain behavior will be assessed using the FLACC(Face, Legs, Activity, Cry, and Consolability) Scale score, during different phases of dental treatment in children with pulpitis receiving local anesthesia. The scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates severe pain. Higher scores indicate greater pain intensity and a worse outcome. |
Baseline (before local anesthetic administration), during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
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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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Physiological indicators (Heart Rate)
時間枠：Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
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Description: Heart rate will be recorded using a blood volume pulse (BVP) sensor during dental treatment. Unit of Measure: Beats per minute (bpm) |
Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
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Physiological indicators (Skin Conductance)
時間枠：Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
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Description: Skin conductance will be measured using electrodermal activity (EDA) sensors during dental treatment. Unit of Measure: MicroSiemens (µS) |
Baseline, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
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Wong-Baker Faces Pain Rating Scale Score
時間枠：Baseline (before local anesthetic administration, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
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Self-reported pain whit Wong-Baker Faces Pain Rating Scale will be recorded at predefined clinical stages of treatment. Scale ranges from 0 to 10 points, where 0 indicates no pain and 10 indicates the worst pain possible |
Baseline (before local anesthetic administration, during anesthetic injection, cavity access (pulpotomy/pulpectomy), and final restoration phase (immediately during procedure)
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Onset of local anesthesia
時間枠：From completion of anesthetic injection until confirmation of pulpal anesthesia during the treatment visit.
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Description: Time elapsed from completion of local anesthetic injection until confirmation of pulpal anesthesia. Pulpal anesthesia will be verified using cold testing (Endo Ice) after confirmation of soft tissue anesthesia. Unit of Measure: Minutes and seconds |
From completion of anesthetic injection until confirmation of pulpal anesthesia during the treatment visit.
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Duration of soft tissue anesthesia
時間枠：From confirmation of soft tissue anesthesia immediately after injection until complete recovery of sensation, assessed up to 6 hours after treatment.
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Description: Time elapsed from confirmed loss of soft tissue sensation following local anesthetic administration until complete recovery of sensation as reported by the participant's caregiver. Unit of Measure: Minutes |
From confirmation of soft tissue anesthesia immediately after injection until complete recovery of sensation, assessed up to 6 hours after treatment.
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Kurien RS, Goswami M, Singh S. Comparative evaluation of anesthetic efficacy of warm, buffered and conventional 2% lignocaine for the success of inferior alveolar nerve block (IANB) in mandibular primary molars: A randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2018 Spring;12(2):102-109. doi: 10.15171/joddd.2018.016. Epub 2018 Jun 20.
- Aulestia-Viera PV, Braga MM, Borsatti MA. The effect of adjusting the pH of local anaesthetics in dentistry: a systematic review and meta-analysis. Int Endod J. 2018 Aug;51(8):862-876. doi: 10.1111/iej.12899. Epub 2018 Feb 21.
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
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