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

NCT07682181 | Not Yet Recruiting

• 1 other identifier: pr.69/IEC/GDCH/KDP/2025-2026
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Local Anesthesia Infiltration

Keywords

local anesthesia; local infiltration; massager; vibrating device; Topical Benzocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• physiologic parameter

  pre and during administration of local anesthesia

Study Arms (3)

benzocaine group

ACTIVE COMPARATOR

20% topical benzocaine

Drug: Topical Benzocaine 20%

vibrating T massager

EXPERIMENTAL

Facial T Massager producing local vibration on mucosal application

Device: Facial T massager

combination

EXPERIMENTAL

combination of benzocaine and massager

Device: Facial T massager; Drug: Topical Benzocaine 20%

Interventions

Facial T massager DEVICE

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

combination; vibrating T massager

Topical Benzocaine 20% DRUG

topical application of mucopain gel for 30 seconds

benzocaine group; combination

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Dental College and Hospital, India: lead

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: 40462040 BACKGROUND

Central Study Contacts

jayachandra Assistant professor, MDS

CONTACT

+91-9490088514; dr.jayachandra2509@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share