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Clinical Trials/NCT04773886
NCT04773886
Completed
Phase 4

To Evaluate the Effectiveness of Mineral Trioxide Aggregate and Platelet Rich Fibrin Along With Biodentine as Pulpotomy Medicament in Patients With Pulpitis.

Maharishi Markendeswar University (Deemed to be University)1 site in 1 country60 target enrollmentFebruary 1, 2020

Overview

Phase
Phase 4
Intervention
Mineral trioxide aggregate
Conditions
Pulpitis - Irreversible
Sponsor
Maharishi Markendeswar University (Deemed to be University)
Enrollment
60
Locations
1
Primary Endpoint
EPT
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of this study was to clinically and radiographically evaluate the effectiveness of MTA, Biodentine, Platelet Rich Fibrin along with Mineral Trioxide Aggregate and Platelet Rich Fibrin along with Biodentine as pulpotomy medicament in patients with pulpitis.

Detailed Description

Sixty systemically healthy patients with irreversible pulpitis were enrolled in the study based on inclusion and exclusion criteria. All the enrolled patients were randomly allocated into 4 groups (15 each) Group I: MTA GROUP: Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent. Group II: BIODENTINE GROUP: Vital Pulpotomy will be done using Biodentine as pulp capping agent. Group III: PRF + MTA GROUP: Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent. Group IV: PRF+ BIODENTINE GROUP: Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent Patients were assessed at 1 day,3 months, 6 months and 9 months postoperatively for pain, pulp sensitivity test, swelling or presence of any sinus tract. All the proposed teeth were assessed radiographically at1 day, 3 months, 6 months and 9 months postoperatively.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
March 12, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Maharishi Markendeswar University (Deemed to be University)
Responsible Party
Principal Investigator
Principal Investigator

DR SURINDER SACHDEVA

PROFESSOR

Maharishi Markendeswar University (Deemed to be University)

Eligibility Criteria

Inclusion Criteria

  • Patients with carious exposed tooth exhibiting clinical and radiographical evidence for pulpitis.
  • Deep caries extending ≥2/3 of dentin.
  • Tooth with positive response with cold testing.
  • Tooth with no mobility.
  • No signs of pulpal necrosis including sinus tract or swelling.
  • Patient approval for the treatment and follow up

Exclusion Criteria

  • Any systemic disease that could influence the outcome.
  • Non-restorable tooth.
  • Teeth with periapical widening.
  • Tooth which cannot be isolated.
  • Teeth with marginal periodontitis or crestal bone loss.
  • Indication of post/ post and core restoration marginal periodontitis with attachment loss \>5mm.
  • Teeth with immature root or calcified canal.
  • Teeth with internal and external resorption.
  • No pulp exposure after caries excavation.
  • Uncontrolled bleeding after access cavity preparation after several minutes N

Arms & Interventions

MTA GROUP

Vital Pulpotomy will be done using Mineral trioxide aggregate(MTA) as pulp capping agent.

Intervention: Mineral trioxide aggregate

BIODENTINE GROUP

Vital Pulpotomy will be done using Biodentine as pulp capping agent.

Intervention: Biodentine

PRF + MTA GROUP

Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent

Intervention: Mineral trioxide aggregate

PRF + MTA GROUP

Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent

Intervention: Platelet rich fibrin

PRF+ BIODENTINE GROUP

Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent.

Intervention: Biodentine

PRF+ BIODENTINE GROUP

Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent.

Intervention: Platelet rich fibrin

Outcomes

Primary Outcomes

EPT

Time Frame: change from baseline to 1day, 3 months, 6 months, 9 months

Electric pulp testing

cold test

Time Frame: change from baseline to 1day, 3 months, 6 months, 9 months

cold test

Secondary Outcomes

  • Tender on percussion(change from baseline to 1day, 3 months, 6 months, 9 months)
  • swelling(change from baseline to 1day, 3 months, 6 months, 9 months)

Study Sites (1)

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