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

Study Overview
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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.

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.

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

Conditions
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Pulpitis - Irreversible

Intervention / Treatment
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* Drug: Mineral trioxide aggregate
* Drug: Biodentine
* Biological: Platelet rich fibrin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EPT | Electric pulp testing | change from baseline to 1day, 3 months, 6 months, 9 months | 
| cold test | 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 | present or absent | change from baseline to 1day, 3 months, 6 months, 9 months | 
| swelling | present or absent | change from baseline to 1day, 3 months, 6 months, 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulpal regeneration, pulpitis, pulpotomy