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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

NCT07302438 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-03-10

No results posted yet for this 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.

Conditions

  • Reversible Pulpitis
  • Deep Carious Lesions

Interventions

PROCEDURE

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

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

PROCEDURE

Mineral Trioxide Aggregate (MTA) for Miniature Pulpotomy

Mineral Trioxide Aggregate (MTA) for miniature pulpotomy. MTA serves as standard of care.

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-25
Primary Completion
2026-12-31
Completion
2027-04-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07302438 on ClinicalTrials.gov