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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-03-12

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

patient and statistician are masked about the treatment modality.

Study Groups

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MTA GROUP

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

Group Type SHAM_COMPARATOR

Mineral trioxide aggregate

Intervention Type DRUG

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

BIODENTINE GROUP

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

Group Type SHAM_COMPARATOR

Biodentine

Intervention Type DRUG

Vital Pulpotomy will be done using Biodentine as pulp capping agent

PRF + MTA GROUP

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

Group Type ACTIVE_COMPARATOR

Mineral trioxide aggregate

Intervention Type DRUG

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

Platelet rich fibrin

Intervention Type 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

PRF+ BIODENTINE GROUP

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

Group Type ACTIVE_COMPARATOR

Biodentine

Intervention Type DRUG

Vital Pulpotomy will be done using Biodentine as pulp capping agent

Platelet rich fibrin

Intervention Type 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

Interventions

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Mineral trioxide aggregate

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

Intervention Type DRUG

Biodentine

Vital Pulpotomy will be done using Biodentine as pulp capping agent

Intervention Type DRUG

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

Intervention Type BIOLOGICAL

Other Intervention Names

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MTA Biodenine

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No