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

Maharishi Markendeswar University (Deemed to be University)

Status and phase: Completed; Phase 4

Conditions: Pulpitis - Irreversible

Treatments: Drug: Biodentine; Biological: Platelet rich fibrin; Drug: Mineral trioxide aggregate

Study type: Interventional

Funder types: Other

Identifiers

NCT04773886

MahrishiMU 1012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

MTA GROUP

Sham Comparator group

Description:

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

Treatment:

Drug: Mineral trioxide aggregate

BIODENTINE GROUP

Sham Comparator group

Description:

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

Treatment:

Drug: Biodentine

PRF + MTA GROUP

Active Comparator group

Description:

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

Treatment:

Drug: Mineral trioxide aggregate

Biological: Platelet rich fibrin

PRF+ BIODENTINE GROUP

Active Comparator group

Description:

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

Treatment:

Drug: Biodentine

Biological: Platelet rich fibrin