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NCT Number: NCT03790540

Pain Assessment During Mandibular Nerve Block Injection With the Aid of Dental Vibe Tool in Pediatric Dental Patients

The purpose of this study is to valuate the effectiveness of DentalVibe(DV) tool in pain reduction during local anesthetic injection compared to traditional injection without aid of DentalVibe in pediatric patients.

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Key information

Conditions

Anesthesia, Local

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

This study is a crossover randomized controlled clinical trial where (N=60 ) children will be selected from the outpatient clinic of Pediatric Dentistry and Public Health Department, Faculty of Dentistry, Alexandria University after securing necessary consents. These children will be selected based on a need for local anesthesia for pulpotomy treatment on both sides of the mandible. All selected children will be randomly allocated into 2 groups. Group I (assigned to injection with the aid of DentalVibe tool), Group II(assigned to conventional injection). Each group will receive 2 mandibular nerve block injections with two different injection techniques, with 1-2 weeks apart as a washing out period. Mandibular nerve block injection will be either with vibration using DentalVibe at the injection side or topical analgesic (benzocaine 20%) gel will be applied before the injection of local anesthesia at first the appointment, and the alternative technique will be used at the second appointment . Injection with the aid of DentalVibe tool will act as the experimental group while the control group will be the use of topical analgesic (benzocaine 20%).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age range from 5-7 years.
  • Patients who are in need of pulpotomy dental treatment requiring bilateral local anesthesia in the mandible.
  • Children free of any systemic disease or special health care needs.
  • Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.

Exclusion criteria

  • Having active sites of pathosis in the area of injection that could affect anesthetic assessment.
  • Signs of irreversible pulpitis or pulp necrosis.
  • Radiographs show periapical or bifurcation radiolucency.
  • Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
  • Patients with acute oral or facial infection (swelling and/or cellulitis).
  • Patients refusing to participate.

Treatment and study plan

DentalVibe

Device

It is a vibrotactile device that aids in reducing pain during local anesthesia injection in pediatric patients

Topical Benzocaine 20%

Drug

Topical benzocaine 20% gel on the mucosal injection site prior to injection

Primary outcomes

  1. Subjective pain reduction during local anesthesia administration.

    Time frame: during administration of local anesthesia

    Pain will be assessed during local anesthesia injection by means of Wong-Baker faces scale. It consists of faces with different facial expression for happiness and pain and is scored from 0-5 as 0 is very happy and feels no pain and 5 is very painful

  2. Objective pain assessment after local anesthesia administration

    Time frame: after performing all injections

    After performing all the injections, pain reaction will be evaluated by two investigators independently using recorded video tapes by Face, Leg, Activity, Cry, Consolability Scale (FLACC).

    The scale comprises the following parameters:

    (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0 to 2, which results in a minimum score of 0 and maximum of 10. According to this scale 0 = relaxed and comfortable (no pain), 1-3 = mild discomfort, 4-6 = moderate pain, and 7-10 = severe discomfort or pain, A lower score represents less physical reaction than does a higher number.

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

Pain Assessment During Mandibular Nerve Block Injection With the Aid of Dental Vibe Tool in Pediatric Dental Patients: A Randomized Controlled Trial.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 31, 2018
Registry last updated
Apr 10, 2020

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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