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

Sponsor
Alexandria University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05857033
Collaborator
(none)
48
Enrollment
1
Location
4
Arms
4.4
Anticipated Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The Participants will be randomly and equally allocated into 2 groups with 2 subgroups eachThe Participants will be randomly and equally allocated into 2 groups with 2 subgroups each
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Effectiveness of Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in the Maxillary Arch in Children: a Randomized Controlled Clinical Trial
Actual Study Start Date :
Jan 5, 2023
Anticipated Primary Completion Date :
May 20, 2023
Anticipated Study Completion Date :
May 20, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 )

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexandria University
ClinicalTrials.gov Identifier:
NCT05857033
Other Study ID Numbers:
  • 0568-12/2022
First Posted:
May 12, 2023
Last Update Posted:
May 12, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alexandria University
Dental injection
Palatal injection
Indirect palatal injection

Study Results

No Results Posted as of May 12, 2023