search
Back to results

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

Primary Purpose

Pulpitis - Irreversible

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Mineral trioxide aggregate
Biodentine
Platelet rich fibrin
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring pulpal regeneration, pulpitis, pulpotomy

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Sham Comparator

Active Comparator

Active Comparator

Arm Label

MTA GROUP

BIODENTINE GROUP

PRF + MTA GROUP

PRF+ BIODENTINE GROUP

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

EPT
Electric pulp testing
cold test
cold test

Secondary Outcome Measures

Tender on percussion
present or absent
swelling
present or absent

Full Information

First Posted
February 22, 2021
Last Updated
March 13, 2021
Sponsor
Maharishi Markendeswar University (Deemed to be University)
search

1. Study Identification

Unique Protocol Identification Number
NCT04773886
Brief Title
Effectiveness of Mineral Trioxide Aggregate and Platelet Rich Fibrin Along With Biodentine. .
Official Title
To Evaluate the Effectiveness of Mineral Trioxide Aggregate and Platelet Rich Fibrin Along With Biodentine as Pulpotomy Medicament in Patients With Pulpitis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi Markendeswar University (Deemed to be University)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible
Keywords
pulpal regeneration, pulpitis, pulpotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model 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.
Masking
ParticipantOutcomes Assessor
Masking Description
patient and statistician are masked about the treatment modality.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MTA GROUP
Arm Type
Sham Comparator
Arm Description
Vital Pulpotomy will be done using Mineral trioxide aggregate(MTA) as pulp capping agent.
Arm Title
BIODENTINE GROUP
Arm Type
Sham Comparator
Arm Description
Vital Pulpotomy will be done using Biodentine as pulp capping agent.
Arm Title
PRF + MTA GROUP
Arm Type
Active Comparator
Arm Description
Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent
Arm Title
PRF+ BIODENTINE GROUP
Arm Type
Active Comparator
Arm Description
Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent.
Intervention Type
Drug
Intervention Name(s)
Mineral trioxide aggregate
Other Intervention Name(s)
MTA
Intervention Description
Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent
Intervention Type
Drug
Intervention Name(s)
Biodentine
Other Intervention Name(s)
Biodenine
Intervention Description
Vital Pulpotomy will be done using Biodentine as pulp capping agent
Intervention Type
Biological
Intervention Name(s)
Platelet rich fibrin
Intervention Description
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 Outcome Measure Information:
Title
EPT
Description
Electric pulp testing
Time Frame
change from baseline to 1day, 3 months, 6 months, 9 months
Title
cold test
Description
cold test
Time Frame
change from baseline to 1day, 3 months, 6 months, 9 months
Secondary Outcome Measure Information:
Title
Tender on percussion
Description
present or absent
Time Frame
change from baseline to 1day, 3 months, 6 months, 9 months
Title
swelling
Description
present or absent
Time Frame
change from baseline to 1day, 3 months, 6 months, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
surinder sachdeva, M.D.S.
Organizational Affiliation
PROFESSOR
Official's Role
Study Director
Facility Information:
Facility Name
Department of Conservative Dentistry and Endodontics, M.M. College of Dental Sciences and Research.
City
Ambāla
State/Province
Haryana
ZIP/Postal Code
133207
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30981748
Citation
Li Y, Sui B, Dahl C, Bergeron B, Shipman P, Niu L, Chen J, Tay FR. Pulpotomy for carious pulp exposures in permanent teeth: A systematic review and meta-analysis. J Dent. 2019 May;84:1-8. doi: 10.1016/j.jdent.2019.03.010. Epub 2019 Apr 11.
Results Reference
background
PubMed Identifier
27994420
Citation
Kumar V, Juneja R, Duhan J, Sangwan P, Tewari S. Comparative evaluation of platelet-rich fibrin, mineral trioxide aggregate, and calcium hydroxide as pulpotomy agents in permanent molars with irreversible pulpitis: A randomized controlled trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):512-518. doi: 10.4103/0976-237X.194107.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs