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

NCT07571278 | Not Yet Recruiting

• 1 other identifier: anesthesia technique-2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia Effectiveness

Keywords

Vibraject; Dental vibe; Pain perception; Inferior alveolar nerve block

Outcome Measures

Primary Outcomes (1)

• Subjective pain 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

Secondary Outcomes (1)

• Objective pain during injection

  Baseline and during injection

Study Arms (3)

Inferior alveolar nerve block Injection using Vibraject system(MiltexInc LLC.,York,PA,USA).

EXPERIMENTAL

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.

Device: Vibraject

Inferior alveolar nerve block Injection using Dentalvibe system (BING Innovations LLC,Crystal La).

EXPERIMENTAL

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.

Device: Dental vibe

Inferior alveolar nerve block Injection using the Conventional Syringe.

ACTIVE COMPARATOR

A conventional metal aspirating syringe

Device: Conventional syringe

Interventions

Vibraject DEVICE

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.

Inferior alveolar nerve block Injection using Vibraject system(MiltexInc LLC.,York,PA,USA).

Dental vibe DEVICE

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.

Inferior alveolar nerve block Injection using Dentalvibe system (BING Innovations LLC,Crystal La).

Conventional syringe DEVICE

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.

Inferior alveolar nerve block Injection using the Conventional Syringe.

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry,Cairo University

Cairo, 11411, Egypt

Location

Study Officials

• Mahmoud H Eid, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Yasmeen MHM Amer, Bachelors

CONTACT

+201124054504; yasmeen.mohamed@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The blinding of operator is not possible due to the nature of the anaesthesic procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)