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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-35
SponsorAll India Institute of Medical Sciences

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

56 Participants
are divided into 2 treatment groups