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

NCT07302438 · tracked via the Priya Life Science India tracker

Sponsor

All India Institute of Medical Sciences

Phase

Not applicable

Started

2026-04-25

Last updated

2026-03-10

Condition(s) studied

Reversible PulpitisDeep Carious Lesions

Investigational drug(s) / intervention(s)

Calcium Silicate doped treated dentin matrix for miniature pulpotomy (CaSi+hTDM MP).Mineral Trioxide Aggregate (MTA) for Miniature Pulpotomy

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.

Study 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.

Eligibility

Sex

ALL

Min age

14 Years

Max age

35 Years

Healthy volunteers

Accepted

Inclusion Criteria: * The healthy participants (ASA 1 and 2), between ages 14 - 35 years, reporting to AIIMS Nagpur from within a 100 kms radius with carious pulp exposure in mature permanent teeth and with the following clinical and radiographic features will be included in the study: I. Clinical features 1. 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) 2. Positive response to pulp sensibility tests. II. Radiographic features 1. Normal periapical tissues \[Periapical index (PAI) score ≤2\](114) 2. The presence of carious lesion with radiolucency penetrating three-fourths (deep caries) or the entire (extremely deep caries) dentin thickness Exclusion Criteria: * The patients with the following clinical and radiographic features will be excluded from the study: I. Clinical features 1. A history of spontaneous unprovoked toothache, pain on percussion, a sinus tract, compromised periodontal status (periodontal pockets \> 4mm), excessive mobility, crack 2. Profuse hemorrhage from exposure site (\>5 minutes) 3. The presence of serous or purulent exudates from the exposure site. 4. Teeth that have experienced traumatic occlusion, non-carious lesions, developmental defects etc. II. Radiographic features 1. The evidence of internal or external resorption, or the calcification of the pulp chamber or canals or presence of condensing osteitis. 2. The presence of radiolucency in the furcation or periapical regions.

Primary outcome measure(s)

Pulp vitality — From enrollment to the end of treatment at 6 months
Pulp vitality assessed by cold testing

Trial sites (2)

Facility	City	Region	Status
AIIMS Nagpur	Nagpur	Maharashtra
AIIMS Nagpur	Nagpur	Maharashtra

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07302438 on ClinicalTrials.gov ↗ ← All trials in India