A study comparing different topical methods to reduce pain and anxiety in children during different dental injections

Phase 3

Not yet recruiting

• Conditions: Dental caries, unspecified,

• Registration Number: CTRI/2025/05/087654
• Lead Sponsor: Dr Heena Poptani

Brief Summary

This is a prospective, randomized, interventional clinical trial. It aims to compare the efficacy of various pre-anesthetic agents i.e. lignocaine spray, benzocaine gel, buzzy device, cryotherapy, xylitol solution during two local anesthesia techniques i.e. intraligamentary and infiltration techniques. Pain management is important in pediatric dentistry for effective behaviour management and also for fostering positive long term attitude of child towards dental care. This study aims to determine the most comfortable local anesthesia technique for pediatric patients.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-30
• Study Start: 2025-05-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 1.Healthy children with no systemic illness, history of allergies• Positive and definitely positive Frankl behaviour rating scale children 2.Children requiring administration of local anesthesia for dental treatment.
• 3.Children with deep carious primary teeth in upper or lower arch excluding primary mandibular second molars 4.Consent provided by parent(s)/guardian(s).
• 5.Children with no previous experience of intraoral local anesthesia.

Exclusion Criteria

• 1.Children with known systemic illness 2.Negative and Definitely negative Frankel behaviour rating scale children 3.Children less than 5 years of age 4.Children with deep carious primary mandibular second molars.
• 5.Children with known allergy to any of the components of local anesthesia or any pre-anesthetic medication included in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain and anxiety assessment using appropriate pain and anxiety scales	At baseline, 2 minutes, 5 minutes and 30 minutes after LA administration

Trial Locations

Locations (1)

Government Dental College and Hospital, Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Government Dental College and Hospital, Nagpur

🇮🇳Nagpur, MAHARASHTRA, India

DR HEENA POPTANI

Principal investigator

7020931450

poptaniheena2000@gmail.com