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

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

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: Local Anesthesia Infiltration
• Intervention / Treatment: Drug: Topical Benzocaine 20%; Device: Facial T massager

Detailed Description

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

1. Group 1: Application of 20% Benzocaine gel for 2 minutes followed by a standard local anesthetic injection.
2. Group 2: Application of Facial Massager on the buccal mucosa 30 seconds prior to and during the injection.
3. 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.
4. 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jayachandra Assistant professor, MDS; Phone Number: +91-9490088514; Email: dr.jayachandra2509@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: benzocaine group; 20% topical benzocaine	Drug: Topical Benzocaine 20%; topical application of mucopain gel for 30 seconds
Experimental: vibrating T massager; Facial T Massager producing local vibration on mucosal application	Device: Facial T massager; vibrating facial T massager used to apply on mucosa for mechanical stimulation and gate control
Experimental: combination; combination of benzocaine and massager	Drug: Topical Benzocaine 20%; topical application of mucopain gel for 30 seconds; Device: Facial T massager; vibrating facial T massager used to apply on mucosa for mechanical stimulation and gate control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self reort of pain	wong-baker faces pain rating scale with face emoji rating no pain as score zero to score ten as that huts worst.	after injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physiologic parameter	measuring heart rate pre and during injection of local Anesthesia	pre and during administration of local anesthesia

Collaborators and Investigators

• Sponsor: Government Dental College and Hospital, India

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: local infiltration; local anesthesia; vibrating device; massager; Topical Benzocaine
• Other Study ID Numbers: pr.69/IEC/GDCH/KDP/2025-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data. The aggregated, analyzed results of this clinical trial comparing the intraoral massager and benzocaine gel will be disseminated via publication in a peer-reviewed scientific journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No