Efficacy of Facial Massager in Reducing Intra Oral Injection Pain in Pediatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Facial T massager, Topical Benzocaine 20%.
- Who it may be relevant to
- Registry conditions: Local Anesthesia Infiltration. Basic parameters: 4 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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.
Overview
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
- Device Facial T massager
vibrating facial T massager used to apply on mucosa for mechanical stimulation and gate control - Drug Topical Benzocaine 20%
topical application of mucopain gel for 30 seconds
Primary outcome measures
- self reort of pain [Time frame: after injection]
Secondary outcome measures (1)
- physiologic parameter [Time frame: pre and during administration of local anesthesia]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 40462040
Identifiers
NCT: NCT07682181 · pr.69/IEC/GDCH/KDP/2025-2026