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

Sponsor

Nourhan M.Aly (Other)

Overall Status

Completed

CT.gov ID

NCT03790540

Collaborator

Alexandria University (Other)

Enrollment

Location

Arms

5.4

Actual Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local	Device: DentalVibe Drug: Topical Benzocaine 20%	Phase 2

Detailed 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%).

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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%).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%).

Masking:

None (Open Label)

Masking Description:

The operator will not be blinded to the type of treatment. However, the statistician will be blinded to the treatment groups.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 1, 2018

Actual Primary Completion Date :

Mar 10, 2019

Actual Study Completion Date :

May 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Injection with the aid of DentalVibe 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 It is a vibrotactile device that aids in reducing pain during local anesthesia injection in pediatric patients
Active Comparator: Injection with topical benzocaine 20% 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% Topical benzocaine 20% gel on the mucosal injection site prior to injection

Arm

Intervention/Treatment

Experimental: Injection with the aid of DentalVibe

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

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

Active Comparator: Injection with topical benzocaine 20%

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%

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

Outcome Measures

Primary Outcome Measures

Subjective pain reduction during local anesthesia administration. [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
Objective pain assessment after local anesthesia administration [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry, Alexandria University	Alexandria		Egypt	21512

Sponsors and Collaborators

Nourhan M.Aly
Alexandria University

Investigators

Principal Investigator: Passant H Hassanein, BDS, Alexandria University
Study Director: Amani M Khalil, PhD, Alexandria University
Study Director: Dalia AM Talaat, PhD, Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Nourhan M.Aly, Clinical Instructor, University of Alexandria

ClinicalTrials.gov Identifier:

NCT03790540

Other Study ID Numbers:

DentalVibe during LA

First Posted:

Dec 31, 2018

Last Update Posted:

Apr 10, 2020

Last Verified:

Apr 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Nourhan M.Aly, Clinical Instructor, University of Alexandria

DentalVibe

Mandibular nerve block injection

Consolability Scale

Additional relevant MeSH terms:

Benzocaine

Study Results

No Results Posted as of Apr 10, 2020