PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars
Outcome of PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars With Irreversible Pulpitis: A Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 2, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedMarch 5, 2021
March 1, 2021
1 year
March 2, 2021
March 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (1)
calcific like bridge
12 month
Study Arms (3)
Portland cement
EXPERIMENTALpulpotomy with PRF and white Portland cement
Mineral trioxide aggregate
EXPERIMENTALpulpotomy with PRF and Mineral trioxide aggregate
Biodentine
EXPERIMENTALpulpotomy with PRF and Biodentine
Interventions
pulpotomy with PRF and white Mineral trioxide aggregate
Eligibility Criteria
You may qualify if:
- spontaneous, lingering pain exacerbated by hot and cold , and/or radiating pain
- Responded to cold and electric pulp testing
You may not qualify if:
- pain on palpation, percussion,
- mobility or swelling
- peridontall widening
- Teeth with marginal periodontitis or crestal bone loss
- resorption
- calcified canals
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of dentistry Fayoum University
Al Fayyum, Egypt
Related 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.
PMID: 22339289BACKGROUNDCushley 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.
PMID: 31229496BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Endodontics
Study Record Dates
First Submitted
March 2, 2021
First Posted
March 5, 2021
Study Start
August 1, 2019
Primary Completion
August 1, 2020
Study Completion
January 1, 2021
Last Updated
March 5, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share