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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07682181

Enrollment

120

Registered

2026-07-02

Start date

2026-06-01

Completion date

2026-12-31

Last updated

2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthesia Infiltration

Keywords

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

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 .

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.

Interventions

DEVICEFacial T massager

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

DRUGTopical Benzocaine 20%

topical application of mucopain gel for 30 seconds

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 12 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
self reort of pain	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

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

Contacts

CONTACTjayachandra Assistant professor, MDS

dr.jayachandra2509@gmail.com+91-9490088514

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026