Clinical trial to compare the effectiveness of three pain reducing methods and two needle gauges in reducing pain and anxiety in children during local anesthesia injection .

Not Applicable

Completed

• Conditions: Persons encountering health services in other specified circumstances, (2) ICD-10 Condition: K040||Pulpitis,

• Registration Number: CTRI/2023/07/055438
• Lead Sponsor: Dr Sai Vaishnavi Alahari

Brief Summary

In clinical pediatric dental practice local anesthesia is of utmost importance as it relieves the pain sensation during dental procedures, making the experience comfortable for the patient. The fear of needles is shown to be one of the main obstacles for avoidance of dental treatment which has no exception in children.  The challenge of  reducing the pain during administering local anesthesia can help reduce fear and anxiety in the child, also helps him to trust the dentist and build a positive attitude towards dental treatment. The current trial aims at comparing three pain alleviating methods TENS, EMLA cream to conventionally used topical spray in combination with two different needle gauges (25 gauge and 30-gauge) as pain alleviating methods during the administration of local anesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-08
• Study Completion: 2025-03-25
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Healthy children with no systemic illness , allergies,etc.
• children requiring local anesthesia administration for dental treatment .
• children with informed parental consent.

Exclusion Criteria

• Children with known systemic disease.
• Children without parental consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare effect of three pain alleviating methods on pain & anxiety levels in children during local anesthesia procedure.	pain & anxiety will be recorded before & after local anesthesia procedure

Secondary Outcome Measures

Name	Time	Method
To compare effect of two needle gauges on pain & anxiety levels in children during local anesthesia procedure.	after local anesthesia procedure

Trial Locations

Locations (1)

Sri sai college of dental surgery; 🇮🇳 Hyderabad, TELANGANA, India

Sri sai college of dental surgery

🇮🇳Hyderabad, TELANGANA, India

Dr Sai Vaishnavi Alahari

Principal investigator

8008733770

saivaishnavialahari@gmail.com