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NOT YET RECRUITING
NCT07302438
NA

Comparative Evaluation of Calcium Silicate-doped Treated Dentin Matrix and Mineral Trioxide Aggregate as Miniature Pulpotomy Biomaterials in Deep Carious Lesions

Sponsor: All India Institute of Medical Sciences

View on ClinicalTrials.gov

Summary

AIM: To compare the efficacy of a Novel calcium silicate doped treated dentin matrix and Mineral Trioxide aggregate as biomaterials for miniature pulpotomy. OBJECTIVES: Primary objective: To evaluate the efficacy of calcium silicate-doped human-treated dentin matrix (CaSi+hTDM) compared to Mineral Trioxide Aggregate (MTA) in maintaining pulp vitality using cold testing following Miniature Pulpotomy (MP) in deep and extremely deep carious lesions with reversible pulpitis in 14- to 35-year-old patients reporting to Department of Dentistry, AIIMS Nagpur. Secondary objectives: 1. To evaluate patient-reported outcomes such as pain, swelling, sinus tract etc. post-operatively. 2. To determine the clinical success rates of both materials by assessing the Periapical index of healing over a 6 months follow-up period. NULL HYPOTHESIS: The null hypothesis (H0) is that there is no difference between CaSi+hTDM and MTA in maintaining pulp vitality when used as a Miniature Pulpotomy (MP) biomaterial in carious lesions.

Official title: Comparative Evaluation of Calcium Silicate-doped Treated Dentin Matrix and Mineral Trioxide Aggregate as Miniature Pulpotomy Biomaterials in Deep Carious Lesions: a Parallel, Double-blind, Randomised Clinical Trial

Key Details

Gender

All

Age Range

14 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-04-25

Completion Date

2027-04

Last Updated

2026-03-10

Healthy Volunteers

Yes

Interventions

PROCEDURE

Calcium Silicate doped treated dentin matrix for miniature pulpotomy (CaSi+hTDM MP).

Calcium Silicate doped treated dentin matrix for miniature pulpotomy (CaSi+hTDM MP).

PROCEDURE

Mineral Trioxide Aggregate (MTA) for Miniature Pulpotomy

Mineral Trioxide Aggregate (MTA) for miniature pulpotomy. MTA serves as standard of care.

Locations (2)

AIIMS Nagpur

Nagpur, Maharashtra, India

AIIMS Nagpur

Nagpur, Maharashtra, India