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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790540
• Other study ID #: DentalVibe during LA
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: April 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 15, 2019
• Est. primary completion date: March 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

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

Drug:
• Topical Benzocaine 20%
Topical benzocaine 20% gel on the mucosal injection site prior to injection

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Sermet Elbay Ü, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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