Comparison of Efficacy of Platelet-rich Fibrin, Mineral Trioxide Aggregate and Calcium Hydroxide as Pulpotomy Medicaments in Permanent Teeth With Irreversible Pulpitis

Of all the various pulpotomy medicaments that have been studied till to date, three agents have been selected for this study to compare their efficacy. CH being the control, MTA being one of the most recommended biomaterial and PRF that in addition to being a biomaterial is an autologous agent. Uptil now there have been no prospective trials using these three pulpotomy agents in mature permanent teeth with irreversible pulpitis in our part of the world and even the international studies that have been done utilized different methodologies with no unanimous conclusion. This is the reason that at present this treatment regime (pulpotomy) showing better perspectives cannot be presented with confidence as a predictable treatment option to the patients with irreversible pulpitis. By virtue of this study this challenge is being undertaken. Hypothesis: ALTERNATE HYPOTHESIS There is a difference between the efficacy of the PRF, MTA and CH when used as pulpotomy medicaments in mature permanent teeth with irreversible pulpitis NULL HPOTHESIS There is no difference in efficacy of the PRF, MTA and CH when used as pulpotomy medicaments in mature permanent teeth with irreversible pulpitis

Full record on ClinicalTrials.gov (NCT ID NCT05266859).

Full results record on ClinicalTrials.gov.

Phase

Phase 2

Study type

Interventional

Allocation

Randomized

Masking

Double-blind

Intervention model

Parallel assignment

Primary purpose

Treatment

Enrollment (final)

114 participants

Started

August 2019

Actually completed

January 2022

Age range: 10–70 · Sex: All · Healthy volunteers: Accepts

1 site participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.