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Clinical Trials/NCT06751316
NCT06751316Not yet recruitingNot Applicable

Clinical and Radiographic Evaluation of MTA Pulpotomy Versus Conventional Pulpectomy in Primary Molars With Irreversible Pulpitis: A Randomized Clinical Trial

Cairo University1 site in 1 country42 target enrollmentStarted: January 1, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
42
Locations
1
Primary Endpoint
• rate of clinical success
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is designed to compare between MTA Pulpotomy (Removal of coronal pulp tissue, placing MTA and covering with Stainless steel crown) Versus Conventional Pulpectomy (Removal of radicular pulp tissue, placing Zinc Oxide/Eugenol and covering with Stainless steel crown) in irreversible pulpitis in primary second molars.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
4 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients:
  • •Aged 4-7 years, cooperative, in good general health and medically within normal
  • •Restorable mandibular second primary molars.
  • •History of irreversible pulpitis.
  • •Preoperative radiograph:
  • •Absence of periapical or inter-radicular radiolucency.
  • •Absence of widening of periodontal ligaments (PDL) space.
  • •Absence of internal or external root resorption.

Exclusion Criteria

  • •Patients:
  • •With systemic disorders.
  • •Physical or mental disabilities.
  • •Unable to attend follow- up visits.
  • •Refusal of Participation.
  • •Refusal to sign the informed consent.
  • •Previously accessed teeth.
  • •Mobile mandibular second primary molar.
  • •Swelling in the vestibule or on palpation.
  • •Pain on percussion.

Arms & Interventions

Conventional Pulpectomy

Experimental

Conventional pulpectomy using Zinc Oxide/Eugenol

Intervention: Conventional Pulpectomy (Procedure)

MTA Pulpotomy

Experimental

Pulpotomy using MTA

Intervention: MTA Pulpotomy (Procedure)

Outcomes

Primary Outcomes

• rate of clinical success

Time Frame: 12 months

* tenderness on percussion and palpation * sinus/parulis/fistula * soft tissue swelling * pathological mobility

Secondary Outcomes

  • • rate of radiographic success(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zeyad Nasr Abdelhafeiz

Principal Investigator

Cairo University

Study Sites (1)

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