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Clinical Trials/NCT06219824
NCT06219824
Not Yet Recruiting
Phase 3

Clinical and Radiographic Evaluation of Bioceramic Putty Mineral Trioxide Aggregate Versus Mineral Trioxide Aggregate in Pulpotomy of Immature Permanent Molars: A Randomized Clinical Trial

Cairo University1 site in 1 country40 target enrollmentNovember 1, 2024

Overview

Phase
Phase 3
Intervention
Conventional MTA
Conditions
Pulpotomy
Sponsor
Cairo University
Enrollment
40
Locations
1
Primary Endpoint
Primary Outcome
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

The present study aims to evaluate the clinical and radiographic success of bioceramics putty MTA versus MTA in the pulpotomy of immature permanent molars

The main question it aims to answer is:

Will the biocermaics putty MTA have higher clinical and radiographic success rates than MTA in pulpotomy of immature permanent molars?

Detailed Description

limited clinical trials have reported the clinical and radiographic outcomes after pulpotomy with premixed putty bioceramic MTA and conventional MTA in young permanent molars. MTA has various drawbacks, such as difficulty in handling, long setting time, discoloration of the tooth, and its form as a powder/liquid which raise the responsibility for major material waste. To conquer these issues, bioceramic materials have been developed premixed putty bioceramic MTA is a ready-to-use material for immediate placement with zero waste, saving cost and chair time. Thus, the present study aims to evaluate bioceramic putty MTA's clinical and radiographic success versus MTA in pulpotomy of immature permanent molars.

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
November 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marwa Abd El-Naby Hussien

Assistant lecturer of Pediatric Dentistry, Faculty of Dentistry, October University for Modern Sciences and Arts

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Patients aged from 6-8 years of both sexes have immature permanent molars
  • with deep carious lesions indicated for pulpotomy.
  • Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
  • Permanent molars without any clinical sign of pulp necrosis including swelling, fistula, pain on percussion, and pathologic tooth mobility.
  • Permanent molars without any adverse radiographic findings including thickening of the periodontal ligament space, radiolucency at the interradicular or periapical regions
  • permanent molars without internal and external root resorption, or calcification in pulp tissue.

Exclusion Criteria

  • Medically compromised patients who have systemic disease.
  • Uncooperative patients who refuse treatment.
  • Permanent molars that were previously restored.

Arms & Interventions

control Group

pulpotomy treatment for the young permanent teeth will be done using conventional powder and liquid Mineral Trioxide Aggregate followed by Glassionomer restoration and stainless steel crown

Intervention: Conventional MTA

Experimental

pulpotomy treatment for the young permanent teeth will be done using premixed ready for use bioceramic MTA followed by Glassionomer restoration and stainless steel crown

Intervention: premixed Bio-ceramic MTA

Outcomes

Primary Outcomes

Primary Outcome

Time Frame: 24hrs, 1 week

Immediate Postoperative pain \[ Time Frame: one week) post operative pain by Verbal analogue scale.It is a 10 cm long horizontal line with points labeled from 0 to 10 where (0) indicates no pain, (1-3) mild pain, (4-6) moderate pain, and (7-10) severe pain.

Secondary Outcomes

  • Secondary outcome(6,12 month)

Study Sites (1)

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