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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

Study acronym: hTDM
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Start date: Jan 2026 to Apr 25, 2026
    • Study completion date: Mar 2027 to Apr 2027
    v3
  2. Interventions: Calcium Silicate doped treated dentin matrix for miniature pulpotomy (CaSi+hTDM MP). (Procedure) to Calcium Silicate doped treated dentin matrix for miniature pulpotomy (CaSi+hTDM MP). (Procedure), Mineral Trioxide Aggregate (MTA) for…
    • Study description shortened, about 70 words
    • Publications: details revised at 1 of 1 entry
    • Study title shortened, about 6 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07302438
Lead Sponsor All India Institute of Medical Sciences
Conditions
(from sponsor)		 Reversible Pulpitis, Deep Carious Lesions
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov