Using Anesthetic Gel Patches to Reduce Pain of Palatal Injection

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

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-02-19

Brief Summary

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Local anesthetic administration step is mandatory step for controlling pain before dental procedures. The aim of this study was to compare effectiveness of topical Benzocaine 18% gel patch form and Benzocaine 20% topical gel in reducing pain during injection of local anesthesia in children receiving dental treatment.

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Detailed Description

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A sample of 50 children ranging in age from 6 to 8 years who need a bilateral dental treatment in the same arch participated in this study. They were healthy children rated 3 or 4 according to Frankl behavioral rating scale. They were selected from the clinic of Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University.

A randomized split mouth design was done in which each child received both tested topical anesthetics on each side of the arch. The topical anesthetic gel patch or the topical gel application was randomly used at the first or second visits. Pain or discomfort was evaluated during injection using sound, eye, motor (SEM) scale, and after injection using faces pain scale- revised (FPS-R).

Conditions

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Anesthesia, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split mouth randomized clinical trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

* Administration of local anesthetic will be video recorded.
* An independent investigator who is blinded to the type of topical applied will evaluate the outcome from the video recordings.

Study Groups

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Intervention group

Topicale® topical anesthetic gel patch (Benzocaine 18%)

Group Type ACTIVE_COMPARATOR

Topicale GelPatch (Benzocaine 18%)

Intervention Type DRUG

Intervention group

control group

Opahl® topical anesthetic gel (Benzocaine 20%)

Group Type PLACEBO_COMPARATOR

Benzocaine oral gel 20%

Intervention Type DRUG

control group

Interventions

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Topicale GelPatch (Benzocaine 18%)

Intervention group

Intervention Type DRUG

Benzocaine oral gel 20%

control group

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Children ranging in age from 6 to 8 years.
2. Healthy children with no contraindications of use of local anesthetics.
3. Cooperative behavior according to Frankl's scale scores 3 or 4. (appendix I)
4. Patients needing dental interventions on both sides in the same arch that will require palatal or inferior alveolar nerve block injections.

Exclusion Criteria

1. Uncooperative children or with intellectual or physical disabilities or medical conditions.
2. Children with acute pain or emergency visits.
3. Children with previous negative dental experience.
4. Children receiving premedications or analgesics 48 hours before testing.
5. children/parents not willing to participate.

Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No