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NCT Number: NCT07571278

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

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.

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Key information

Conditions

Anesthesia Effectiveness

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Subjective pain during injection

    Time frame: 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.

Secondary outcomes

  1. Objective pain during injection

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yasmeen MHM Amer, Bachelors

CONTACT

[email protected]

+201124054504

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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