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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-05-15

Brief Summary

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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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Detailed Description

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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%).

Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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%).

Primary Study Purpose

OTHER

Blinding Strategy

NONE

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

Study Groups

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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.

Group Type EXPERIMENTAL

DentalVibe

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Topical Benzocaine 20%

Intervention Type DRUG

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

Interventions

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DentalVibe

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

Intervention Type DEVICE

Topical Benzocaine 20%

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No