Actively Recruiting

Phase 2
Age: 4Years - 6Years
All Genders
Healthy Volunteers
ID06293521

Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries: A Randomized Clinical Trial

Led by Cairo University · Updated on 2025-12-24

40

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the treatment outcomes of Pulpotomy and Pulpectomy in managing vital primary teeth affected by deep caries with irreversible pulpitis symptoms. It focuses on children aged 4 to 6 years and addresses the traditional and modern approaches to treating inflamed primary dental pulp, exploring the potential for regenerative therapies using calcium silicate-based materials like mineral trioxide aggregate (MTA). Participants will receive one of two treatments: the experimental MTA Pulpotomy or the active comparator Partial Pulpectomy using chlorhexidine irrigation and zinc oxide-eugenol paste for obturation. The pulpotomy involves removing the coronal pulp and placing a special MTA mix over the radicular pulp, while the pulpectomy involves extirpation of pulp tissue, canal preparation, and filling followed by a stainless steel crown restoration. During the study, children will be monitored at multiple time points up to 12 months with radiographic assessments at 6 and 12 months and clinical effectiveness checks at 3, 6, 9, and 12 months. Researchers will also observe child cooperation and record the time until the final restoration is performed. The total participation includes treatment and follow-up visits to evaluate success and safety of the procedures.

CONDITIONS

Brief Title

Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries

Who Can Participate

Age: 4Years - 6Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Child is aged between 4 and 6 years and in good general health
  • Parents have provided written informed consent
  • Child has spontaneous pain and a deep carious lesion with pulp exposure and bleeding that does not stop within five minutes after coronal pulp removal
  • Tooth is restorable
Not Eligible

You will not qualify if you...

  • Child has physical or mental disability
  • Child is unable to attend follow-up visits
  • Affected tooth has been previously accessed or treated
  • Presence of swelling, tenderness to percussion or palpation, or abnormal tooth mobility
  • Pre-operative radiographic signs of resorption or radiolucency around root or furcation areas

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day 0

Participants receive either pulpotomy or partial pulpectomy procedures to manage primary teeth with deep caries.

1 treatment visit (in-person)

Follow-up

Duration - 12 months

Participants are monitored for clinical effectiveness and radiographic success of the treatment.

Visits at Day 0, Month 3, Month 6, Month 9, and Month 12

Trial Site Locations

Total: 1 location

1

Cairo University

Cairo, Egypt

Actively Recruiting

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Research Team

N

Nada Mostafa, B.D.S

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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