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

NCT04773886 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: MahrishiMU 1012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis - Irreversible

Keywords

pulpal regeneration; pulpitis; pulpotomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Tender on percussion

  change from baseline to 1day, 3 months, 6 months, 9 months

• swelling

  change from baseline to 1day, 3 months, 6 months, 9 months

Study Arms (4)

MTA GROUP

SHAM COMPARATOR

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

Drug: Mineral trioxide aggregate

BIODENTINE GROUP

SHAM COMPARATOR

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

Drug: Biodentine

PRF + MTA GROUP

ACTIVE COMPARATOR

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

Drug: Mineral trioxide aggregate; Biological: Platelet rich fibrin

PRF+ BIODENTINE GROUP

ACTIVE COMPARATOR

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

Drug: Biodentine; Biological: Platelet rich fibrin

Interventions

Mineral trioxide aggregate DRUG

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

Also known as: MTA

MTA GROUP; PRF + MTA GROUP

Biodentine DRUG

Vital Pulpotomy will be done using Biodentine as pulp capping agent

Also known as: Biodenine

BIODENTINE GROUP; PRF+ BIODENTINE GROUP

Platelet rich fibrin 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 + MTA GROUP; PRF+ BIODENTINE GROUP

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maharishi Markendeswar University (Deemed to be University): lead

Study Sites (1)

Department of Conservative Dentistry and Endodontics, M.M. College of Dental Sciences and Research.

Ambāla, Haryana, 133207, India

Location

Related Publications (2)

• Li Y, Sui B, Dahl C, Bergeron B, Shipman P, Niu L, Chen J, Tay FR. Pulpotomy for carious pulp exposures in permanent teeth: A systematic review and meta-analysis. J Dent. 2019 May;84:1-8. doi: 10.1016/j.jdent.2019.03.010. Epub 2019 Apr 11.

  PMID: 30981748 BACKGROUND

• Kumar V, Juneja R, Duhan J, Sangwan P, Tewari S. Comparative evaluation of platelet-rich fibrin, mineral trioxide aggregate, and calcium hydroxide as pulpotomy agents in permanent molars with irreversible pulpitis: A randomized controlled trial. Contemp Clin Dent. 2016 Oct-Dec;7(4):512-518. doi: 10.4103/0976-237X.194107.

  PMID: 27994420 BACKGROUND

MeSH Terms

Conditions

Pulpitis

Interventions

mineral trioxide aggregate; Pemetrexed; tricalcium silicate

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• surinder sachdeva, M.D.S.

  PROFESSOR

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patient and statistician are masked about the treatment modality.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 26, 2021
• Study Start: February 1, 2020
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)