Conventional Versus Computer-Assisted Dental Anesthesia
24 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
29
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Nuevo León
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Montemorelos, Nuevo León, Mexique, 67530
- University Dental Clinic, Montemorelos University School of Dentistry
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
Autres noms:
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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain perception during local anesthetic administration
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Dental anxiety
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Jose L Jimenez-Ortiz, DDS, Montemorelos University School of Dentistry
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
2 septembre 2025
Achèvement primaire (Réel)
2 décembre 2025
Achèvement de l'étude (Réel)
2 décembre 2025
Dates d'inscription aux études
Première soumission
20 juillet 2026
Première soumission répondant aux critères de contrôle qualité
24 juillet 2026
Première publication (Réel)
28 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- UM-ESEST-2025-015
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .