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

Not Applicable

Active, not recruiting

• Conditions: Anesthesia, Local
• Interventions: Other: Buccal and direct palatal injection with the aid of Buzzy; Other: Buccal and indirect palatal injection with the aid of Buzzy; Other: Buccal and direct palatal injection without Buzzy; Other: Buccal and indirect palatal injection without Buzzy

• Registration Number: NCT05857033
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-05
• Status Verified: 2023-04
• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-12
• Last Update Posted: 2023-05-12
• Primary Completion: 2023-05-20
• Study Completion: 2023-05-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct local anesthesia with Buzzy	Buccal and direct palatal injection with the aid of Buzzy	-
Indirect local anesthesia with Buzzy	Buccal and indirect palatal injection with the aid of Buzzy	-
Direct local anesthesia	Buccal and direct palatal injection without Buzzy	-
Indirect local anesthesia	Buccal and indirect palatal injection without Buzzy	-

Primary Outcome Measures

Name	Time	Method
Change in pain scores	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.
Change in child's behavior	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

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt