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

Sponsor

Maharishi Markendeswar University (Deemed to be University) (Other)

Overall Status

Completed

CT.gov ID

NCT04773886

Collaborator

(none)

Enrollment

Location

Arms

13.3

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulpitis - Irreversible	Drug: Mineral trioxide aggregate Drug: Biodentine Biological: Platelet rich fibrin	Phase 4

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Double (Participant, Outcomes Assessor)

Masking Description:

patient and statistician are masked about the treatment modality.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Actual Primary Completion Date :

Mar 12, 2021

Actual Study Completion Date :

Mar 12, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

EPT [change from baseline to 1day, 3 months, 6 months, 9 months]
Electric pulp testing
cold test [change from baseline to 1day, 3 months, 6 months, 9 months]
cold test

Secondary Outcome Measures

Tender on percussion [change from baseline to 1day, 3 months, 6 months, 9 months]
present or absent
swelling [change from baseline to 1day, 3 months, 6 months, 9 months]
present or absent

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Conservative Dentistry and Endodontics, M.M. College of Dental Sciences and Research.	Ambāla	Haryana	India	133207

Sponsors and Collaborators

Maharishi Markendeswar University (Deemed to be University)

Investigators

Study Director: surinder sachdeva, M.D.S., PROFESSOR

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

DR SURINDER SACHDEVA, PROFESSOR, Maharishi Markendeswar University (Deemed to be University)

ClinicalTrials.gov Identifier:

NCT04773886

Other Study ID Numbers:

MahrishiMU 1012

First Posted:

Feb 26, 2021

Last Update Posted:

Mar 16, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by DR SURINDER SACHDEVA, PROFESSOR, Maharishi Markendeswar University (Deemed to be University)

pulpal regeneration

pulpitis

pulpotomy

Additional relevant MeSH terms:

Pulpitis

Study Results

No Results Posted as of Mar 16, 2021