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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04773886
Enrollment
60
Registered
2021-02-26
Start date
2020-02-01
Completion date
2021-03-12
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpitis - Irreversible

Keywords

pulpal regeneration, pulpitis, pulpotomy

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.

Interventions

DRUGMineral trioxide aggregate

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

DRUGBiodentine

Vital Pulpotomy will be done using Biodentine as pulp capping agent

BIOLOGICALPlatelet 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

Sponsors

Maharishi Markendeswar University (Deemed to be University)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

patient and statistician are masked about the treatment modality.

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cold testchange from baseline to 1day, 3 months, 6 months, 9 monthscold test
EPTchange from baseline to 1day, 3 months, 6 months, 9 monthsElectric pulp testing

Secondary

MeasureTime frameDescription
Tender on percussionchange from baseline to 1day, 3 months, 6 months, 9 monthspresent or absent
swellingchange from baseline to 1day, 3 months, 6 months, 9 monthspresent or absent

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026