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

NCT03790540 | Completed Phase 2

• 1 other identifier: DentalVibe during LA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Local

Keywords

DentalVibe; Mandibular nerve block injection; Consolability Scale

Outcome Measures

Primary Outcomes (2)

• Subjective pain reduction during local anesthesia administration.

  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

  during administration of local anesthesia

• Objective pain assessment after local anesthesia administration

  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.

  after performing all injections

Study Arms (2)

Injection with the aid of DentalVibe

EXPERIMENTAL

1 mL of Mepivacaine HCl 2%, 1/20000 Levonordefrin will be injected using a 27 gauge dental needle. DentalVibe is a small, handheld cordless device that has a charging docking station. A demonstration of DentalVibe (DV) will be performed by putting it into direct contact with the children's nails before applying the device intraorally. Then, the device will be placed on the oral mucosa to enclose the injection site before administering local anesthesia and Potential subject-expectancy effects and pressure from the placement of DV will be controlled. The device will be turned on to stimulate the area of needle penetration. After 5 seconds of vibration, the needle will be inserted. The device will continue vibrating during needle insertion and anesthetic injection.

Device: DentalVibe

Injection with topical benzocaine 20%

ACTIVE COMPARATOR

Topical anesthesia -Benzocaine gel 20%. Tissues will be dried using (2 X 2) gauze to enhance the absorption of the benzocaine gel 20% around the site of the needle penetration and will be left in contact with the soft tissue for one minute. Then the local anesthetic solution (1 ml Mepivacaine HCl 2%, 1/20000 Levonordefrin) will be injected using a 27 gauge dental needle.

Drug: Topical Benzocaine 20%

Interventions

DentalVibe DEVICE

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

Injection with the aid of DentalVibe

Topical Benzocaine 20% DRUG

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

Injection with topical benzocaine 20%

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (4)

• Sermet Elbay U, Elbay M, Yildirim S, Kaya E, Kaya C, Ugurluel C, BaydemIr C. Evaluation of the injection pain with the use of DentalVibe injection system during supraperiosteal anaesthesia in children: a randomised clinical trial. Int J Paediatr Dent. 2016 Sep;26(5):336-45. doi: 10.1111/ipd.12204. Epub 2015 Sep 15.

  PMID: 26369274 BACKGROUND

• Hutchins HS Jr, Young FA, Lackland DT, Fishburne CP. The effectiveness of topical anesthesia and vibration in alleviating the pain of oral injections. Anesth Prog. 1997 Summer;44(3):87-9.

  PMID: 9481967 BACKGROUND

• Ram D, Peretz B. The assessment of pain sensation during local anesthesia using a computerized local anesthesia (Wand) and a conventional syringe. J Dent Child (Chic). 2003 May-Aug;70(2):130-3.

  PMID: 14528773 BACKGROUND

• Nanitsos E, Vartuli R, Forte A, Dennison PJ, Peck CC. The effect of vibration on pain during local anaesthesia injections. Aust Dent J. 2009 Jun;54(2):94-100. doi: 10.1111/j.1834-7819.2009.01100.x.

  PMID: 19473149 BACKGROUND

Study Officials

• Passant H Hassanein, BDS

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Amani M Khalil, PhD

  Alexandria University

  STUDY DIRECTOR

• Dalia AM Talaat, PhD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The operator will not be blinded to the type of treatment. However, the statistician will be blinded to the treatment groups.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Instructor

Model Details: 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%).

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: December 31, 2018
• Study Start: December 1, 2018
• Primary Completion: March 10, 2019
• Study Completion: May 15, 2019
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

EG (1)