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

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.

NCT Number	NCT07302438
Lead Sponsor	All India Institute of Medical Sciences
Conditions	Reversible Pulpitis, Deep Carious Lesions
Enrollment	56 participants
Start Date	2026-04-25
Primary Completion	2026-12 (estimated)
Study Completion	2027-04 (estimated)
Updated on ClinicalTrials.gov	2026-03-10