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 .

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.

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.

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.