NCT07783217

Brief Summary

The goal of this clinical trial is to learn if MTA pulpotomy compared to pulpectomy have the same clinical and radiographic success in treatment of primary molars diagnosed with symptomatic irreversible pulpitis. The main questions it aims to answer are: Does MTA pulpotomy compared to pulpectomy have the same clinical and radiographic success in treatment of primary molars diagnosed with symptomatic irreversible pulpitis?

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Jul 2025Jan 2027

Study Start

First participant enrolled

July 15, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

1.5 years

First QC Date

August 16, 2026

Last Update Submit

August 19, 2026

Conditions

Irreversible Pulpitis

Keywords

MTA Pulpotomy

Outcome Measures

Primary Outcomes (1)

  • proportion of treated teeth demonstrating clinical and functional success during follow up intervals

    score 0 was applied for non functional teeth and score 1 was applied for functional teeth

    at 3-month postoperatively, at 6-month postoperatively, at 12-month postoperatively, at 18-month postoperatively

Study Arms (2)

Pulpotomy group

EXPERIMENTAL
Biological: MTA pulp dressing material

Pulpectomy group

ACTIVE COMPARATOR
Biological: Metapex

Interventions

MTA pulp dressing materialBIOLOGICAL

The patients with symptomatic irreversible pulpitis in their primary molars was treated by MTA pulpotomy

Pulpotomy group
MetapexBIOLOGICAL

The patients with symptomatic irreversible pulpitis in their primary molars was treated by Metapex pulpectomy

Pulpectomy group

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • healthy and cooperative children
  • primary mandibular second molars with deep carious lesions and vital pulp
  • restorable crowns
  • history of spontaneous persistent lingering pain
  • normal radiographic appearance

You may not qualify if:

  • clinical signs and symptoms of pulp necrosis
  • radiographic evidence of pathological root resorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University Dental Hospita

Minya, Egypt

Location

MeSH Terms

Interventions

Metapex

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

August 16, 2026

First Posted

August 24, 2026

Study Start

July 15, 2025

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Last Updated

August 24, 2026

Record last verified: 2026-08

Locations

EG(1)