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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nisanur Müdüroğlu, DDS
- Numéro de téléphone: 905434631893
- E-mail: nsnr_mdr@hotmail.com
Sauvegarde des contacts de l'étude
- Nom: Merve Bilmez Selen, PhD
- Numéro de téléphone: 905457673098
Lieux d'étude
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Malatya
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Malatya, Malatya, Turquie (Türkiye), 44280
- Recrutement
- Inonu University Faculty of Dentistry
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Contact:
- nisanur müdüroğlu
- Numéro de téléphone: 905434631893
- E-mail: nisanur.muduroglu@inonu.edu.tr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Inferior Alveolar Nerve Block Group
Participants receiving conventional inferior alveolar nerve block anesthesia for mandibular permanent molars requiring emergency endodontic treatment.
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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.
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Expérimental: Digital Anesthesia Group
Participants receiving computer-controlled digital anesthesia for mandibular permanent molars requiring emergency endodontic treatment.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Anesthesia success during endodontic treatment
Délai: During the procedure
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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.
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During the procedure
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Heart rate changes
Délai: Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
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Heart rate will be recorded at predefined time points to evaluate physiological stress response during anesthesia administration and treatment.
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Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Blood pressure changes
Délai: Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
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Blood pressure will be measured at predefined time points to assess the physiological stress response associated with the anesthesia techniques.
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Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2025/8393
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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