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Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe

5 mai 2026 mis à jour par: Yasmeen Mohamed Hussein Mohamed Amer, Cairo University

Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe: A Randomized Controlled Clinical Trial

This RCT study aims to establish evidence based decision comparing between Vibraject (MiltexInc LLC.,York,PA,USA).and Dental vibe(BING Innovations LLC,Crystal Lake,IL,USA versus Conventional Syringe on pain perception during inferior alveolar nerve block anesthesia in lower primary molars indicated for extraction,pulp therapy and cavity preparation in Children.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

This randomized controlled clinical trial aims to compare pain perception of Vibraject and dental vibe during inferior alveolar nerve block in lower primary molars indiacted for extraction,pulp therapy and cavity preparation in children aged 6-8 years.

Pain during local anesthesia remains a major concern in pediatric dentistry, as it contributes significantly to fear, anxiety, and uncooperative behavior in children. Vibration devices, based on the gate control theory of pain, have been introduced as a non-pharmacological method to reduce injection discomfort.

Ninety children will be randomly allocated into 3 parallel groups(1:1:1): Inferior alveolar nerve block Injection using Vibraject system,Inferior alveolar nerve block Injection using Dentalvibe system, Inferior alveolar nerve block Injection using the Conventional Syringe.

All participants will undergo standardized procedures, including topical anesthesia application followed by local anesthetic injection using articaine. Pain perception during injection will be assessed using both subjective and objective measures.

The primary outcome is subjective pain perception during injection measured using Wong-Baker Scale,While secondary outcome is objective pain perception during injection measured using FLACC Scale,Finally The Physiological parameters(heart rate, oxygen saturation )will be measured at two time points: baseline and during injection using pulse oximeter device on child's index finger.

The Findings of this study aims to provide evidence-based guidance on the optimal non pharmacological technique to enhance pain-controlled dental procedures allowing better quality of dental treatment and Improve the patient's cooperation and acceptance for future dental visits.

Type d'étude

Interventionnel

Inscription (Estimé)

90

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.

Coordonnées de l'étude

Lieux d'étude

  • Egypte
      • Cairo, Egypte, 11411
        • Faculty of Dentistry,Cairo University
        • Contact:

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

  • Enfant

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • Children aged 6-8 years.
  • Cooperative children (Rating 3 or 4 based on the Frankl behaviour scale).
  • Medically fit children (ASA I).
  • Children mentally capable of communication.
  • First dental visit (no previous history of injection of LA).
  • Patient requiring extraction/pulp therapy/cavity preparation in mandibular primary molars

Exclusion Criteria:

  • Uncooperative patient (other than 3 or 4 based on the Frankl behaviour scale).
  • Medically unfit children (other than ASA 1).
  • Parental refusal of participation.
  • Children under medications (antibiotics and analgesics) for the previous 48 hours that could alter the pain perception.
  • Children who are allergic to local anaesthesia.

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: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Inferior alveolar nerve block Injection using Vibraject system(MiltexInc LLC.,York,PA,USA).
VibraJect is a compact, battery-operated unit that attaches directly to a standard dental syringe, generating high-frequency vibrations along the needle to attenuate pain during anesthetic delivery. If these devices prove efficacy, they may offer a rapid, non-pharmacologic method to enhance the comfort of children undergoing local anesthesia.
Dispositif: Vibraject

Familiarize the child with the Vibraject device, allowing them to feel the vibrations on their hand to reduce anxiety.

Dry the injection site with sterile gauze. Apply 20% benzocaine gel for 1 minute using a cotton swab.

Use a conventional syringe with the Vibraject attachment, 4% articaine (1:100,000 epi), and a 27-gauge long needle.

Deliver an inferior alveolar and lingual nerve block. Slowly deposit 1.5 mL of anesthetic over at least 60 seconds to minimize discomfort.

Use the FLACC scale (objective) during injection and the Wong-Baker FACES scale (subjective) immediately after.

Monitor heart rate and oxygen saturation via pulse oximetry at baseline and during injection.

Confirm anesthesia after 3-5 minutes via numbness (subjective) and lack of pain during instrumentation (objective).

Perform (extraction or pulp therapy or cavity preparation) per AAPD guidelines. Provide post-operative instructions to the parent and evaluate the need for a space maintainer.
Expérimental: Inferior alveolar nerve block Injection using Dentalvibe system (BING Innovations LLC,Crystal La).
The DentalVibe device is a cordless, rechargeable instrument that produces controlled, pulsed micro-vibrations at the injection site. It features a U-shaped vibrating tip connected to a microprocessor-driven VibraPulse motor, allowing gentle stimulation of sensory receptors, illumination of the injection area, and retraction of the cheek or lip.
Dispositif: Dental vibe

Familiarize the child with the DentalVibe device, letting them feel the vibrations on the back of their hand.

Dry the mucosa with gauze and apply 20% benzocaine gel for 1 minute. Apply the DentalVibe to the buccal mucosa for pre-injection vibration. Using a conventional syringe (4% articaine, 1:100,000 epi, 27G needle), perform the mandibular block simultaneously while the DentalVibe is active.

Slowly deposit 1.5 mL (1.0 mL alveolar / 0.5 mL lingual) over at least 60 seconds.

Evaluate pain using the FLACC scale (during) and the Wong-Baker FACES scale (after).

Record heart rate and oxygen saturation at baseline and during the injection. After 3-5 minutes, confirm anesthesia via subjective numbness and objective lack of pain during instrumentation.

Perform treatment (extraction/pulp therapy/cavity prep) per AAPD guidelines. Provide post-operative care instructions and assess the need for space maintainers.
Comparateur actif: Inferior alveolar nerve block Injection using the Conventional Syringe.
A conventional metal aspirating syringe
Dispositif: Conventional syringe

Dry the injection site with sterile gauze. Apply 20% benzocaine gel for 1 minute using a cotton swab to ensure surface numbing.

Use a conventional metal aspirating syringe with 4% articaine (1:100,000 epi) and a 27-gauge long needle.

Deliver a mandibular inferior alveolar nerve block. Slowly deposit 1.5 mL total (1.0 mL for the alveolar nerve and 0.5 mL for the lingual nerve) over a minimum of 60 seconds.

Evaluate pain using the FLACC scale (during) and the Wong-Baker FACES scale (after).

Record heart rate and oxygen saturation at baseline and during the injection. After 3-5 minutes, confirm anesthesia via subjective numbness and objective lack of pain during instrumentation.

Perform (extraction, pulp therapy, or cavity preparation) according to AAPD guidelines.

Provide post-operative care instructions and evaluate the patient for potential space maintainer requirements.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Subjective pain during injection
Délai: during injection
Wong-Baker Scale: represents a series of faces from a 0-value happy face (which represents lack of pain) to a 10-value crying face (which suggests the worst possible pain). On this basis, the patient chooses the face that best describes his/her level of pain.
during injection

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Objective pain during injection
Délai: Baseline and during injection

Faces, Legs, Arms, Crying, Consolability (FLACC) scale: a measurement tool used to assess the intensity of pain for young children and infants or children that are unable to communicate their pain with exposed body and limbs. The scale is scored in a range of 0-10 with 0 representing no pain. The observation lasts for 2-5 minutes. Each parameter is evaluated on a scale from 0 to 2; the total score is interpreted as follows: 0=relaxed and comfortable, 1-3=mild discomfort, 4- 6=moderate pain, 7-10=severe discomfort/pain.

- Physiological parameters (heart rate, oxygen saturation ) at two time points: baseline, during injection using pulse oximeter Pulse oximetry: non-invasive monitoring technique that measures the heart rate and the oxygen saturation in the blood by shining light at specific wavelengths through tissue, most commonly the fingernail bed, pulse oximetry is the standard of care to use pulse oximetry to monitor oxygen saturation for patients receiving anesthesia.
Baseline and during injection

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cairo University

Les enquêteurs

  • Directeur d'études: Mahmoud H Eid, Professor, Cairo University

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 (Estimé)

1 mai 2026

Achèvement primaire (Estimé)

1 août 2026

Achèvement de l'étude (Estimé)

1 août 2027

Dates d'inscription aux études

Première soumission

30 avril 2026

Première soumission répondant aux critères de contrôle qualité

30 avril 2026

Première publication (Réel)

6 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • anesthesia technique-2026

Plan pour les données individuelles des participants (IPD)

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NON

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

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