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

ConditionLocal Anesthesia Infiltration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorGovernment Dental College and Hospital, India

About this 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 .

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 4-12 years requiring local anesthesia

Cooperative behaviour (frankl rating 3,4)

Disqualifiers

History of allergy to benzocaine

acute infection at the site

special healthcare needs affecting sensory perception

Medically compromised children

Trial design

Design model

Parallel

Treatments tested in this trial

  • Facial T massager

    Device

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

  • Topical Benzocaine 20%

    Drug

    topical application of mucopain gel for 30 seconds

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: benzocaine groupActive comparator 1 intervention
Group B: vibrating T massagerExperimental treatment 1 intervention
Group C: combinationExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
after injection

Secondary outcomes

1

physiologic parameter

measuring heart rate pre and during injection of local Anesthesia

Time frame
pre and during administration of local anesthesia

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Government Dental College and Hospital, India

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: