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Using a Cooling Device to Make Dental Injections Less Painful for Kids

Effectiveness of Extraoral Cooling Device-Assisted Local Anesthetic Administration on Pain Perception in Pediatric Patients: A Randomized Split-Mouth Crossover Clinical Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109132
Enrollment
24
Registered
2026-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K023- Arrested dental caries

Interventions

Intervention1: Exocool device- pre-anesthetic cooling method: The Exocool device will be applied at the injection site for 30â??60 seconds before administration of local anesthesia. Immediately after

Sponsors

Vigneshwaran V
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: This study include 30 children aged 6 to 12 years who are in good general health . Children with a Frankl behaviour rating of three and four. Who have no prior experience with LA and require bilateral maxilla treatment (extraction and pulp therapy) of treatment requiring administration of local anesthesia (LA) in the maxilla

Exclusion criteria

Exclusion criteria: Medically compromised children with active pathosis in the injection region and any history of allergy to LA will be excluded from the study

Design outcomes

Primary

MeasureTime frame
Pain perception during administration of local anesthesiaTimepoint: Pain will be assessed at baseline (before injection), during administration of local anesthesia, and immediately after injection.

Secondary

MeasureTime frame
Change in pulse rate measured using pulse oximeter at baseline, during, & after local anesthetic injection. Anxiety level assessed using Modified Child Dental Anxiety Scale prior to procedure. Child behavior during injection assessed using Frankl Behavior Rating Scale.Timepoint: Baseline During After the procedure

Countries

India

Contacts

Public ContactDr Maheshkumar K

SRM Kattankulathur Dental College and Hospital

kmaheshkumarbds@gmail.com7010950226

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026