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NCT04784949 Clinical Trial

PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars

Irreversible Pulpitis Clinical Trial

Official title:
Outcome of PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars With Irreversible Pulpitis: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04784949
Other study ID # PRF Pulp
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date January 1, 2021

Study information
Verified date March 2021
Source Fayoum University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

this study aimed to compare the clinical and radiographic outcomes of full pulpotmy after application of Biodentine, or MTA, or Portland cement above PRF membrane In permanent molars with irreversible pulpitis

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date January 1, 2021
Est. primary completion date August 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - spontaneous, lingering pain exacerbated by hot and cold , and/or radiating pain - Responded to cold and electric pulp testing Exclusion Criteria: - pain on palpation, percussion, - mobility or swelling - peridontall widening - Teeth with marginal periodontitis or crestal bone loss - resorption - calcified canals

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• portland cement
pulpotomy with PRF and white Portland cement
• Mineral trioxide aggregate
pulpotomy with PRF and white Mineral trioxide aggregate
• Biodentine
pulpotomy with PRF and Biodentine

Locations
Country Name City State
Egypt Faculty of dentistry Fayoum University Fayoum

Sponsors (1)
Lead Sponsor Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Asgary S, Eghbal MJ. Treatment outcomes of pulpotomy in permanent molars with irreversible pulpitis using biomaterials: a multi-center randomized controlled trial. Acta Odontol Scand. 2013 Jan;71(1):130-6. doi: 10.3109/00016357.2011.654251. Epub 2012 Feb 20. — View Citation

Cushley S, Duncan HF, Lappin MJ, Tomson PL, Lundy FT, Cooper P, Clarke M, El Karim IA. Pulpotomy for mature carious teeth with symptoms of irreversible pulpitis: A systematic review. J Dent. 2019 Sep;88:103158. doi: 10.1016/j.jdent.2019.06.005. Epub 2019 Jun 20. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in postoperative pain persistence , relief , or exacerbation of pain using visual analogue scale for pain score 24 hours, 48 hours, 1 week, every 3 months for 12 months
Primary Change in swelling appearance of periapical swelling or facial swelling after the clinical procedures (Binary outcome: Yes/No) 24 hours, 48 hours, 1 week, every 3 months for 12 months
Primary Change in Mobility appearance of teeth mobility after the clinical procedures (record of periodontal pocket depth) 24 hours, 48 hours, 1 week, every 3 months for 12 months
Secondary calcific like bridge measure of the calcific bridge thickness using CBCT 12 month
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