NCT05857033

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
Last Updated

May 12, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

April 26, 2023

Last Update Submit

May 10, 2023

Conditions

Anesthesia, Local

Keywords

Dental injectionPalatal injectionIndirect palatal injection

Outcome Measures

Primary Outcomes (2)

  • Change in pain scores

    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

    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

Study Arms (4)

Direct local anesthesia with Buzzy

EXPERIMENTAL
Other: Buccal and direct palatal injection with the aid of Buzzy

Indirect local anesthesia with Buzzy

EXPERIMENTAL
Other: Buccal and indirect palatal injection with the aid of Buzzy

Direct local anesthesia

ACTIVE COMPARATOR
Other: Buccal and direct palatal injection without Buzzy

Indirect local anesthesia

ACTIVE COMPARATOR
Other: Buccal and indirect palatal injection without Buzzy

Interventions

Buccal and direct palatal injection with the aid of BuzzyOTHER

Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and direct palatal injection

Direct local anesthesia with Buzzy
Buccal and indirect palatal injection with the aid of BuzzyOTHER

Children are assigned to local anesthesia after using the Buzzy vibration unit extraorally for 2 minutes using buccal and indirect palatal injection

Indirect local anesthesia with Buzzy
Buccal and direct palatal injection without BuzzyOTHER

Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and direct palatal injection

Direct local anesthesia
Buccal and indirect palatal injection without BuzzyOTHER

Children are assigned to local anesthesia after using topical analgesic gel (benzocaine 20%) intraorally for 1 minute using buccal and indirect palatal injection

Indirect local anesthesia

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Related Publications (1)

  • Hambouta HM, Sharaf DA, Wahba NA. Effectiveness of cold vibratory stimuli on pain perception governing infiltration anesthesia in the maxillary arch in children: a randomized controlled clinical trial. BMC Oral Health. 2025 Jun 3;25(1):900. doi: 10.1186/s12903-025-06170-4.

    PMID: 40462040DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The Participants will be randomly and equally allocated into 2 groups with 2 subgroups each
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 12, 2023

Study Start

January 5, 2023

Primary Completion

May 20, 2023

Study Completion

May 20, 2023

Last Updated

May 12, 2023

Record last verified: 2023-04

Locations

EG(1)