Effectiveness of Mineral Trioxide Aggregate and Platelet Rich Fibrin Along With Biodentine. .

March 13, 2021 updated by: DR SURINDER SACHDEVA, Maharishi Markendeswar University (Deemed to be University)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Ambāla, Haryana, India, 133207
        • Department of Conservative Dentistry and Endodontics, M.M. College of Dental Sciences and Research.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • No bleeding at all at the time of access opening
  • Pregnant or nursing women.
  • Individual hypersensitive or allergic to any product used in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: MTA GROUP
Vital Pulpotomy will be done using Mineral trioxide aggregate(MTA) as pulp capping agent.
Drug: Mineral trioxide aggregate
Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent
Other Names:
  • MTA
Sham Comparator: BIODENTINE GROUP
Vital Pulpotomy will be done using Biodentine as pulp capping agent.
Drug: Biodentine
Vital Pulpotomy will be done using Biodentine as pulp capping agent
Other Names:
  • Biodenine
Active Comparator: PRF + MTA GROUP
Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent
Drug: Mineral trioxide aggregate
Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent
Other Names:
  • MTA
Biological: Platelet rich fibrin

10 ml of blood was drawn from the peripheral vein in the selected patients with the help of sterilized disposable syringe and blood was collected in the pre-sterilized borosilicate glass test tube, without any addition of anticoagulant and was immediately centrifuged at 3000 rpm for 15 minutes in a centrifuge unit.

The product obtained after centrifugation consisted of three layers:

  • Acellular platelet plasma- top most layer
  • Platelet rich fibrin -middle layer
  • Red blood corpuscles- bottom layer PRF was then separated from the red blood corpuscles base with the help of sterile tweezers and scissors and squeezed with the help of sterile gauze piece
Active Comparator: PRF+ BIODENTINE GROUP
Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent.
Drug: Biodentine
Vital Pulpotomy will be done using Biodentine as pulp capping agent
Other Names:
  • Biodenine
Biological: Platelet rich fibrin

10 ml of blood was drawn from the peripheral vein in the selected patients with the help of sterilized disposable syringe and blood was collected in the pre-sterilized borosilicate glass test tube, without any addition of anticoagulant and was immediately centrifuged at 3000 rpm for 15 minutes in a centrifuge unit.

The product obtained after centrifugation consisted of three layers:

  • Acellular platelet plasma- top most layer
  • Platelet rich fibrin -middle layer
  • Red blood corpuscles- bottom layer PRF was then separated from the red blood corpuscles base with the help of sterile tweezers and scissors and squeezed with the help of sterile gauze piece

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EPT
Time Frame: change from baseline to 1day, 3 months, 6 months, 9 months
Electric pulp testing
change from baseline to 1day, 3 months, 6 months, 9 months
cold test
Time Frame: change from baseline to 1day, 3 months, 6 months, 9 months
cold test
change from baseline to 1day, 3 months, 6 months, 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tender on percussion
Time Frame: change from baseline to 1day, 3 months, 6 months, 9 months
present or absent
change from baseline to 1day, 3 months, 6 months, 9 months
swelling
Time Frame: change from baseline to 1day, 3 months, 6 months, 9 months
present or absent
change from baseline to 1day, 3 months, 6 months, 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maharishi Markendeswar University (Deemed to be University)

Investigators

  • Study Director: surinder sachdeva, M.D.S., Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

March 12, 2021

Study Completion (Actual)

March 12, 2021

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 13, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MahrishiMU 1012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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