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