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

NCT07302438 | Not Yet Recruiting DMC

• 2 other identifiers: IEC/Pharmac/2024/1|04CTRI/2025/04/084767
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief 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. 1.To evaluate patient-reported outcomes such as pain, swelling, sinus tract etc. post-operatively.
2. 2.To determine the clinical success rates of both materials by assessing the Periapical index of healing over a 6 months follow-up period.

Conditions

Reversible Pulpitis; Deep Carious Lesions

Keywords

Human treated dentin matrix; Mineral Trioxide Aggregate; Calcium silicate

Outcome Measures

Primary Outcomes (1)

• Pulp vitality

  Pulp vitality assessed by cold testing

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Standard of Care arm: (Control group) Mineral Trioxide Aggregate (MTA) for miniature pulpotomy

EXPERIMENTAL

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

Procedure: Mineral Trioxide Aggregate (MTA) for Miniature Pulpotomy

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

EXPERIMENTAL

Procedure/Surgery: Calcium Silicate doped treated dentin matrix for miniature pulpotomy (CaSi+hTDM MP). Description: Calcium Silicate doped treated dentin matrix for miniature pulpotomy (CaSi+hTDM MP).

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

Interventions

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

Mineral Trioxide Aggregate (MTA) for Miniature Pulpotomy PROCEDURE

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

Standard of Care arm: (Control group) Mineral Trioxide Aggregate (MTA) for miniature pulpotomy

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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.
• II. Radiographic features
• 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

You may not qualify if:

• The patients with the following clinical and radiographic features will be excluded from the study:
• I. Clinical features
• 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.
• II. Radiographic features
• The evidence of internal or external resorption, or the calcification of the pulp chamber or canals or presence of condensing osteitis.
• The presence of radiolucency in the furcation or periapical regions.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (2)

AIIMS Nagpur

Nagpur, Maharashtra, 441108, India

Location

AIIMS Nagpur

Nagpur, Maharashtra, 441108, India

Location

Related Publications (1)

• Clementino MA, Gomes MC, Pinto-Sarmento TC, Martins CC, Granville-Garcia AF, Paiva SM. Perceived Impact of Dental Pain on the Quality of Life of Preschool Children and Their Families. PLoS One. 2015 Jun 19;10(6):e0130602. doi: 10.1371/journal.pone.0130602. eCollection 2015.

  PMID: 26090927 BACKGROUND

MeSH Terms

Interventions

mineral trioxide aggregate; Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

DR GANESH R JADHAV, MDS

CONTACT

+919823649979; drganesh2009.aiims@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: April 25, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)