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Comparative evaluation of Exocool device and topical anesthetic gel in reducing injection pain in pediatric dental patients

Comparative evaluation of Exocool device and topical anesthetic gel in reducing injection pain in pediatric dental patients : a Randomized split mouth clinical study - NIL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113808
Enrollment
35
Registered
2026-07-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

None listed

Interventions

Intervention1: Exocool device: Assesment of level of anxiety and pain experienced by children during local anaesthetic injection when exocool device is used Intervention2: EXOCOOL DEVICE: Assessment o

Sponsors

Subbaiah Institute of Dental Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 8 to 12 years Children requiring bilateral dental procedures necessitating local anaesthetic injection in the same arch Children with Frankl behaviour rating III or IV Children in good general health ASA I

Exclusion criteria

Exclusion criteria: Children with known allergy or hypersensitivity to anaesthetic agents Children with systemic diseases or medical conditions contraindicating dental treatment ASA II and above Children with neurological psychological or developmental disorders affecting pain perception or behaviour Children with special health care needs Children with acute dental infection swelling or abscess at the injection site Children with a history of adverse reaction to cold or cryotherapy Children who refuse treatment or are uncooperative Frankl I or II

Design outcomes

Primary

MeasureTime frame
Assessment of injection pain using Visual analogue scale and FLACC scaleTimepoint: Baseline before dental treatment during treatment Post treatment 10 to 15 minutes after dental treatment

Secondary

MeasureTime frame
Heart rate blood pressure oxygen saturationTimepoint: Baseline before dental treatment during dental treatment post treatment 10 minutes after dental treatment

Countries

India

Contacts

Public ContactDr Sushma K

Subbaiah Institute of Dental Sciences

drmahanteshat@gmail.com9945955550

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026