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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device 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
• Device 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 us
• Device 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). Re

Primary outcome measures

• Subjective pain during injection [Time frame: during injection]

Secondary outcome measures (1)

• Objective pain during injection [Time frame: Baseline and during injection]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Dentistry,Cairo University — Cairo

Identifiers

NCT: NCT07571278 · anesthesia technique-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗