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

Deep Caries Clinical Trial

— MTA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06219824
• Other study ID #: 14422022599195
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 1, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Marwa Ad Hussien, MSD
• Phone: 01222156972
• Email: marwa.hussien[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: May 30, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

Inclusion Criteria:

• • Patients aged from 6-8 years of both sexes have young 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, 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.

Related Conditions & MeSH terms

• Deep Caries
• Pulpotomy

Intervention

Drug:
• premixed Bio-ceramic MTA
pulpotomy treatment will be done and the premixed bioceramic MTA will be applied in the pulp chamber
• Conventional MTA
pulpotomy treatment will be done and powder and liquid MTA will be mixed and applied in the pulp chamber

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome	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.	1 week
Secondary	Secondary outcome	The increase in root length, The root lengthening will be assessed in Mm through Digora software	3,6,9,12 month