Comparative Evaluation of Calcium Silicate-doped Treated Dentin Matrix and Mineral Trioxide Aggre… (NCT07302438) | Clinical Trial Compass
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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
India56 participantsStarted 2026-04-25
Plain-language 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.
Who can participate
Age range14 Years – 35 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The clinical diagnosis of reversible pulpitis characterized by mild pain (on Numerical Rating Scale 11) that goes away within a couple of seconds following the removal of the stimulus (113)
✓. Positive response to pulp sensibility tests.
✓. Normal periapical tissues \[Periapical index (PAI) score ≤2\](114)
✓. The presence of carious lesion with radiolucency penetrating three-fourths (deep caries) or the entire (extremely deep caries) dentin thickness
Exclusion criteria
✕. A history of spontaneous unprovoked toothache, pain on percussion, a sinus tract, compromised periodontal status (periodontal pockets \> 4mm), excessive mobility, crack
✕. Profuse hemorrhage from exposure site (\>5 minutes)
✕. The presence of serous or purulent exudates from the exposure site.
✕. Teeth that have experienced traumatic occlusion, non-carious lesions, developmental defects etc.
✕
What they're measuring
1
Pulp vitality
Timeframe: From enrollment to the end of treatment at 6 months