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

Pulpitis - Irreversible Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773886
• Other study ID #: MahrishiMU 1012
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: March 12, 2021

Study information

• Verified date: March 2021
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 12, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

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

Biological:
• Platelet 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

Locations

Country	Name	City	State
India	Department of Conservative Dentistry and Endodontics, M.M. College of Dental Sciences and Research.	Ambala	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi Markendeswar University (Deemed to be University)

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EPT	Electric pulp testing	change from baseline to 1day, 3 months, 6 months, 9 months
Primary	cold test	cold test	change from baseline to 1day, 3 months, 6 months, 9 months
Secondary	Tender on percussion	present or absent	change from baseline to 1day, 3 months, 6 months, 9 months
Secondary	swelling	present or absent	change from baseline to 1day, 3 months, 6 months, 9 months