Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in in Children

May 10, 2023 updated by: Alexandria University

Effectiveness of Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in the Maxillary Arch in Children: a Randomized Controlled Clinical Trial

Local anesthesia injections are sometimes painful, resulting in antagonistic cooperation, fear, and anxiety in children. This study aims to investigate the effectiveness of vibratory and cold stimulation before the injection to reduce pain. Purpose of the study: Evaluate the effectiveness of Buzzy® in pain reduction during local anesthesia administration compared to the traditional topical anesthetic gel in pediatric patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who are in need of extraction of maxillary posterior teeth.
  • Children free of any systemic disease or special health care needs (ASA I).
  • Children with no learning disabilities.
  • Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
  • Patients whose parents will give consent to participate.

Exclusion Criteria:

  • Having active sites of pathosis in the area of injection that could affect the anesthetic assessment.
  • Signs of reversible pulpitis.
  • Restorable tooth.
  • 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 cellulites )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Direct local anesthesia with Buzzy
Other: Buccal and direct palatal injection with the aid of Buzzy
Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and direct palatal injection
Experimental: Indirect local anesthesia with Buzzy
Other: Buccal and indirect palatal injection with the aid of Buzzy
Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and indirect palatal injection
Active Comparator: Direct local anesthesia
Other: Buccal and direct palatal injection without Buzzy
Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and direct palatal injection
Active Comparator: Indirect local anesthesia
Other: Buccal and indirect palatal injection without Buzzy
Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and indirect palatal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain scores
Time Frame: Baseline and up to 1 hour
Visual Analogue Scale is used and it ranges from 0 to 10. the ''0'' point indicates ''no pain'' and ''10'' point indicates the worst possible pain.
Baseline and up to 1 hour
Change in child's behavior
Time Frame: During the procedure

Sound, eye,motor (SEM) scale is used. it assess child's pain perception by observing discomfot levels on SEM during injections.

Total scores for SEM range from 0 to 9 based on 0-3 score for each parameter. Score 0: Comfort Score 1: Mild disocomfort Score 2: Moderate discomfort Score 3: Severe discomfort
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2023

Primary Completion (Anticipated)

May 20, 2023

Study Completion (Anticipated)

May 20, 2023

Study Registration Dates

First Submitted

April 26, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0568-12/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia, Local

Clinical Trials on Buccal and direct palatal injection with the aid of Buzzy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe