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

Phase 4

Completed

• Conditions: Pulpitis - Irreversible
• Interventions: Drug: Mineral trioxide aggregate; Drug: Biodentine; Biological: Platelet rich fibrin

• Registration Number: NCT04773886
• Lead Sponsor: Maharishi Markendeswar University (Deemed to be University)

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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-26
• Status Verified: 2021-03
• Primary Completion: 2021-03-12
• Study Completion: 2021-03-12
• Last Update Submitted: 2021-03-13
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MTA GROUP	Mineral trioxide aggregate	Vital Pulpotomy will be done using Mineral trioxide aggregate(MTA) as pulp capping agent.
BIODENTINE GROUP	Biodentine	Vital Pulpotomy will be done using Biodentine as pulp capping agent.
PRF + MTA GROUP	Mineral trioxide aggregate	Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent
PRF + MTA GROUP	Platelet rich fibrin	Vital Pulpotomy will be done using PRF and Mineral trioxide aggregate (MTA) as pulp capping agent
PRF+ BIODENTINE GROUP	Biodentine	Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent.
PRF+ BIODENTINE GROUP	Platelet rich fibrin	Vital Pulpotomy will be done using PRF and Biodentine as pulp capping agent.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Conservative Dentistry and Endodontics, M.M. College of Dental Sciences and Research.; 🇮🇳 Ambāla, Haryana, India