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Clinical Trials/CTRI/2024/06/068984
CTRI/2024/06/068984Not yet recruitingPhase 2

Preserving Vitality- Comparative evaluation of three bioactive materials used in pulpotomy of mature permanent teeth

Mohil Kale1 site in 1 country45 target enrollmentStarted: July 1, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
45
Locations
1
Primary Endpoint
Reduction of pain measured by VAS score

Study Overview

Brief Summary

Until recently, the pulp of mature tooth exposed by caries was considered as a "doomed organ", with pulp extirpitation and root canal treatment being the standard treatment protocol

In cases involving pulp exposure to the level of coronal pulp, pulpotomy has emerged as a treatment protocol as it aids in preserving the vitality of the tooth

Preservation of pulpal vitality of of paramount importance as vital functioning of pulp is capable of initiating several important functions such as formation of dentin, providing nutritive support, enabling a defensive function and possessing a unique regenerative capacity

Pulpotomy is a procedure which involves removal of inflammed coronal pulpal tissue and replacing it with a suitable material, leaving vital radicular pulp within the canals

The advent of newer bioactive materials like Mineral Trioxide Aggregate (MTA), Biodentine and bioceramics have significantly increased the prognosis of vital pulp therapy

The aim of this study is to evaluate and compare performance of three different bioactive materials as pulpotomy agents in mature permanent molars

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Mandibular molars with caries extending to pulp and having symptoms of irreversible pulpitis with positive response to vitality tests (Cold test+EPT).

Exclusion Criteria

  • Teeth that will not respond to vitality tests (Cold+EPT) Teeth with periapical involvement Individuals having Systemic diseases or on antibiotics Teeth having excessive bleeding after cavity preparation (Haemostasis not achieved within 5 minutes of coronal pulp removal).

Outcomes

Primary Outcomes

Reduction of pain measured by VAS score

Time Frame: Baseline

Secondary Outcomes

  • Elimination of pain measured by VAS score(After 7 days, 1 month, 3 months, 6 months, 1 year)
  • No pathosis evident on radiograph(After 7 days, 1 month, 3 months, 6 months, 1 year)

Investigators

Sponsor
Mohil Kale
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Mohil Kale

College Of Dental Sciences And Research Center

Study Sites (1)

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