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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

ConditionsReversible PulpitisDeep 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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

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

  • Mineral Trioxide Aggregate (MTA) for Miniature Pulpotomy

    Procedure/Surgery

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

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Standard of Care arm: (Control group) Mineral Trioxide Aggregate (MTA) for miniature pulpotomyExperimental treatment 1 intervention
Group B: Calcium Silicate doped treated dentin matrix for miniature pulpotomy (CaSi+hTDM MP).Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pulp vitality

Pulp vitality assessed by cold testing

Time frame
From enrollment to the end of treatment at 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

All India Institute of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: