Skip to content

Does using cold saline for final rinse reduces pain in children undergoing pulpectomy

Comparative evaluation of intracanal Saline as final irrigation at 2-4 C and 13-15 C Versus Room-Temperature on Post-Operative Pain over 48 Hours in Single visit Pulpectomy: A Parallel three arm Randomized Clinical Trial. - Nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/090335
Enrollment
66
Registered
2025-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Crotherapy final irrigation: Cold Saline final irrigation at two Cryotherapy temperatures of 2-4 and 13 to 15 degrees. Control Intervention1: Room temperature saline: Room temperature s

Sponsors

All India Institute Of Medical Sciences Raipur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 4 8 years requiring pulpectomy in primary molars. Primary molars with irreversible pulpitis both symptomatic and asymptomatic but with restorable crown structure. Roots showing minimal root resorption Medically healthy children ASA Class I with no systemic diseases that could affect pain perception or healing. Children whose parents/guardians are willing to give consent for participation in the study and post operative pain assessment via video calling. Children classified as Frankl s positive or definitely positive 3 or 4 to ensure successful treatment completion.

Exclusion criteria

Exclusion criteria: Primary molars with severe carious destruction, periapical pathology causing extensive bone loss, or furcation involvement. Less than 2/3rd of the root intact. Children with bleeding disorders, special healthcare needs, immunocompromised conditions, or congenital heart diseases requiring antibiotic prophylaxis. Children taking anti-inflammatory or analgesic medications within 24 hours before treatment. Children with uncooperative behaviour (Frankl s negative or definitely negative: 1 or 2) that may interfere with the study procedure. Any known allergy to local anaesthetics, medicaments, or irrigation solutions used in the study. Children whose parents/guardians are not willing to give consent for participation in the study and post operative pain assessment via video calling. Cases with obturation material extruded beyond the apex. Gingival laceration owing to rubber dam clamp placement.

Design outcomes

Primary

MeasureTime frame
postoperative pain reduction among patients undergoing single-visit pulpectomy using two different cryotherapy temperatures versus room-temperature saline as final intracanal irrigationTimepoint: preoperative, 6, 12, 24,48 hours

Secondary

MeasureTime frame
Post operative analgesic requirementTimepoint: preoperative, 6, 12, 24,48 hours

Countries

India

Contacts

Public ContactPalakjeet Kaur Rissam

AIIMS RAIPUR

virat@aiimsraipur.edu.in9216274600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026