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Pain Reduction Using Vibration and Topical Anesthesia

NCT06804616 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-02

No results posted yet for this study

Summary

The goal of this clinical trial is to study if a powered toothbrush providing vibrations compared with 20% benzocaine topical gel is more effective in reducing pain before local anesthetic injections in children aged 6-12 years undergoing dental procedures. The main questions it aims to answer are:

Does the powered toothbrush reduce pain more effectively than the 20% benzocaine topical gel? How do children perceive and respond to each method using subjective and objective pain measurement tools?

Researchers will compare the use of a powered toothbrush to 20% benzocaine topical gel to see which method minimizes pain during infiltration anesthesia in pediatric patients.

Participants will:

Be divided into two groups:

Group A: Receive 20% benzocaine topical gel before injection. Group B: Use a powered toothbrush at the injection site before administration. Report pain levels using the Wong-Baker FACES Pain Scale and have their pain responses measured using the SEM Scale.

Study Details:

Randomized clinical trial with convenience sampling. Inclusion criteria: Children aged 6-12 years, ASA I classification, and positive Frankl behavior rating.

Exclusion criteria: Intellectual impairments, allergies to local anesthesia, or systemic health conditions.

Study duration: \[November 2024 to December 2024\].

Ethical Considerations:

Participation is voluntary, with informed consent required. Responses will remain confidential, and all ethical guidelines will be followed.

Conditions

  • Pain Management

Interventions

DRUG

20% benzocaine Gel

Participants in this group received 20% Benzocaine Gel applied to the injection site for 5 minutes prior to local anesthesia administration. The gel acts as a topical anesthetic to numb the area and reduce pain perception during the injection procedure.

DEVICE

Powered Toothbrush

Participants in this group received vibration stimulation using a powered toothbrush applied to the injection site for 1 minute before the local anesthesia injection. The vibration works on the principle of gate control theory, aiming to disrupt pain signals and reduce discomfort during the injection procedure.

Sponsors & Collaborators

  • University of Lahore

    lead OTHER

Principal Investigators

  • Irsam Haider, BDS, MCPS · University of Lahore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-28
Primary Completion
2024-12-30
Completion
2025-02-03
FDA Drug
Yes
FDA Device
Yes

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06804616 on ClinicalTrials.gov