Status:

NOT_YET_RECRUITING

Comparison of 3Mixtatin Pulpotomy and Metapex Pulpectomy in Primary Molars With Irreversible Pulpitis

Lead Sponsor:

Cairo University

Conditions:

Irreversible Pulpitis

Primary Teeth

Eligibility:

All Genders

4-9 years

Phase:

PHASE1

Brief Summary

The present study aims to evaluate the clinical and radiographic success of pulpotomy using 3Mixtatin versus pulpectomy using Metapex in primary molars with irreversible pulpitis in children aged 4 to...

Detailed Description

Primary teeth play an essential role in esthetics, phonatics, and mastication, that's why they should be preserved as the best space maintainers until their proper exfoliation time. Various pulp thera...

Eligibility Criteria

Inclusion

  • Children aged from 4 to 9 years with vital primary molars showing signs of irreversible pulpitis.
  • Children with spontaneous pain lasting a few seconds to several hours.
  • Pain is intensified by thermal stimulus and persists after its removal.
  • Pulp hemorrhage after performing access cavity and deroofing of pulp chamber showing reddish pink healthy pulp tissue.
  • Radicular pulp health is verified by achieving hemostasis within eight minutes of compression using a cotton pellet with 5% sodium hypochlorite.
  • Absence of peri-apical or inter-radicular radiolucency, widening of periodontal ligament space, internal or external root resorption.

Exclusion

  • Unrestorable primary molars.
  • Primary molars with uncontrolled pulp hemorrhage or pulp necrosis.
  • Medically compromised patients who have systemic disease.
  • Uncooperative children who refuse treatment.
  • Children whose parents are unwilling to place stainless steel crowns.
  • Children whose parents or caregivers refuse to participate in the study or are unable to attend follow-up visits.

Key Trial Info

Start Date :

June 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2026

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06925490

Start Date

June 1 2025

End Date

October 1 2026

Last Update

April 27 2025

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