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Completed

NCT Number: NCT04773886

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

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.

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Key information

Conditions

Pulpitis - Irreversible Dental Pulp Diseases Pulpitis Stomatognathic Diseases Tooth Diseases

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Conservative Dentistry and Endodontics, M.M. College of Dental Sciences and Research.

Ambāla, Haryana, 133207, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mineral Trioxide Aggregate

Drug

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

Other names: MTA

Biodentine

Drug

Vital Pulpotomy will be done using Biodentine as pulp capping agent

Other names: Biodenine

Platelet rich fibrin

Biological

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

Primary outcomes

  1. EPT

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

    Electric pulp testing

  2. cold test

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

    cold test

Secondary outcomes

  1. Tender on percussion

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

    present or absent

  2. swelling

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

    present or absent

Sponsors and collaborators

Lead sponsor

Maharishi Markendeswar University (Deemed to be University)

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2021
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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