Status:

NOT_YET_RECRUITING

Treatment Outcomes of Pulpotomy Versus Pulpectomy in Vital Primary Molars Diagnosed With Irreversible Pulpitis

Lead Sponsor:

Qatar University

Collaborating Sponsors:

Jordan University of Science and Technology

Primary Health Care Corporation, Qatar

Conditions:

Irreversible Pulpitis

Eligibility:

All Genders

4-9 years

Phase:

NA

Brief Summary

This randomised controlled trial aims to compare treatment outcomes between pulpotomy and pulpectomy when used to treat vital primary molars diagnosed with symptomatic irreversible pulpitis. Compared ...

Detailed Description

Background: Pulpectomy continues to be the standard treatment recommendation for management of vital primary molars diagnosed with symptomatic irreversible pulpitis. The recent decade has seen a parad...

Eligibility Criteria

Inclusion

  • Healthy (ASA I and II) co-operative children (Frankl Scale + and ++) between the ages of four and nine years.
  • Participants have symptoms typical of irreversible pulpitis in one of the primary molars.
  • The pulp of the affected primary molar is vital.
  • Radicular pulp health is confirmed by attainment of radicular pulp haemostasis within 6 minutes of coronal pulp amputation.
  • The affected primary molars can be restored with full coverage stainless steel crowns.
  • Any physiologic root resorption, if present, is less than ⅓ the root length.

Exclusion

  • Clinical examination of affected primary molar reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis/fistula, or soft tissue swelling).
  • Pre-operative periapical radiograph suggests presence of periapical radiolucency or pathologic root resorption.
  • Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate).
  • Signs of extensive radicular pulp inflammation i.e., root pulp bleeding continues even after 6-min.
  • Parents not willing to place full coverage crowns post-treatment.
  • Clinical diagnosis of irreversible pulpitis between two adjacent primary molars is not sharply defined.
  • Unable to perform clinical procedure under rubber dam

Key Trial Info

Start Date :

July 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2028

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06904781

Start Date

July 1 2025

End Date

June 30 2028

Last Update

April 11 2025

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