Clinical and Radiographic Evaluation of Bioceramic Putty MTA Versus MTA in Pulpotomy of Immature Permanent Molars

Phase 3

Not yet recruiting

• Conditions: Pulpotomy; Deep Caries
• Interventions: Drug: premixed Bio-ceramic MTA; Drug: Conventional MTA

• Registration Number: NCT06219824
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2024-01-01
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Study Start: 2024-11-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	premixed Bio-ceramic MTA	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
control Group	Conventional MTA	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

Primary Outcome Measures

Name	Time	Method
Primary Outcome	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 Outcome Measures

Name	Time	Method
Secondary outcome	6,12 month	The increase in root length, The root lengthening will be assessed in Mm through Digora software

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Cairo, Egypt