Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07682181

Efficacy of Facial Massager in Reducing Intra Oral Injection Pain in Pediatric Patients

Abstract

* Background: Local anesthesia is a primary source of anxiety in pediatric dentistry. * Objective: To evaluate if mechanical vibration from a low-cost facial massager reduces pain and anxiety during injections using the Gate Control Theory. * Design: Prospective Randomized Controlled Trial .

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Local Anesthesia Infiltration

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Methodology & Study Design

  • Setting: Pediatric Dental Department, Kadapa, Andhra Pradesh.
  • Inclusion Criteria: Children aged 4-12 years requiring local anesthesia, cooperative (frankl 3,4)
  • Exclusion Criteria: History of allergy to benzocaine, acute infection at the site, or special healthcare needs affecting sensory perception, Medically compromised, unco-operative children, those who do not consent.

Intervention Protocol

  • Group 1: Application of 20% Benzocaine gel for 2 minutes followed by a standard local anesthetic injection.
  • Group 2: Application of Facial Massager on the buccal mucosa 30 seconds prior to and during the injection.
  • Group 3: Application of 20% Benzocaine gel for 2 minutes + Facial Massager applied to the buccal mucosa 30 seconds prior to and during the injection.
  • Infection Control & Sterilization

To ensure patient safety, the following protocol for the non-medical T-massager will be implemented:

  • Barrier Protection: The device will be encased in a single-use, disposable polyethylene sleeve (Digital Sensor Sleeve) and secured with tape.
  • Disinfection: After barrier removal, a "Double-Wipe" method using 70% Isopropyl Alcohol wipe will be used.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 4-12 years requiring local anesthesia
  • Cooperative behaviour (frankl rating 3,4)

Exclusion criteria

  • History of allergy to benzocaine
  • acute infection at the site
  • special healthcare needs affecting sensory perception
  • Medically compromised children
  • unco-operative children
  • those who do not consent.

Treatment and study plan

Facial T massager

Device

vibrating facial T massager used to apply on mucosa for mechanical stimulation and gate control

Topical Benzocaine 20%

Drug

topical application of mucopain gel for 30 seconds

Primary outcomes

  1. self reort of pain

    Time frame: after injection

    wong-baker faces pain rating scale with face emoji rating no pain as score zero to score ten as that huts worst.

Secondary outcomes

  1. physiologic parameter

    Time frame: pre and during administration of local anesthesia

    measuring heart rate pre and during injection of local Anesthesia

Study contacts

Contact information is provided by the study sponsor or research team.

jayachandra Assistant professor, MDS

CONTACT

[email protected]

+91-9490088514

Sponsors and collaborators

Lead sponsor

Government Dental College and Hospital, India

Other Gov

Registry information

Official study title

Efficacy of a Vibrating Facial-T- Massager as an Adjunct to Topical Anesthesia in Reducing Intraoral Injection Pain in Children: A Randomized Controlled Trial.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.