Back to resultsPRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars
Primary Purpose
Irreversible Pulpitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
portland cement
Mineral trioxide aggregate
Biodentine
Sponsored by
About this trial
This is an interventional treatment trial for Irreversible Pulpitis focused on measuring PRF, Vital pulp therapy, pulpotomy, bioceramics
Eligibility Criteria
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
Sites / Locations
- Faculty of dentistry Fayoum University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Portland cement
Mineral trioxide aggregate
Biodentine
Arm Description
pulpotomy with PRF and white Portland cement
pulpotomy with PRF and Mineral trioxide aggregate
pulpotomy with PRF and Biodentine
Outcomes
Primary Outcome Measures
Change in postoperative pain
persistence , relief , or exacerbation of pain using visual analogue scale for pain score
Change in swelling
appearance of periapical swelling or facial swelling after the clinical procedures (Binary outcome: Yes/No)
Change in Mobility
appearance of teeth mobility after the clinical procedures (record of periodontal pocket depth)
Secondary Outcome Measures
calcific like bridge
measure of the calcific bridge thickness using CBCT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04784949
Brief Title
PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars
Official Title
Outcome of PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars With Irreversible Pulpitis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis
Keywords
PRF, Vital pulp therapy, pulpotomy, bioceramics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
permanent molar with symptomatic irreversible pulpitis
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Portland cement
Arm Type
Experimental
Arm Description
pulpotomy with PRF and white Portland cement
Arm Title
Mineral trioxide aggregate
Arm Type
Experimental
Arm Description
pulpotomy with PRF and Mineral trioxide aggregate
Arm Title
Biodentine
Arm Type
Experimental
Arm Description
pulpotomy with PRF and Biodentine
Intervention Type
Procedure
Intervention Name(s)
portland cement
Intervention Description
pulpotomy with PRF and white Portland cement
Intervention Type
Procedure
Intervention Name(s)
Mineral trioxide aggregate
Intervention Description
pulpotomy with PRF and white Mineral trioxide aggregate
Intervention Type
Procedure
Intervention Name(s)
Biodentine
Intervention Description
pulpotomy with PRF and Biodentine
Primary Outcome Measure Information:
Title
Change in postoperative pain
Description
persistence , relief , or exacerbation of pain using visual analogue scale for pain score
Time Frame
24 hours, 48 hours, 1 week, every 3 months for 12 months
Title
Change in swelling
Description
appearance of periapical swelling or facial swelling after the clinical procedures (Binary outcome: Yes/No)
Time Frame
24 hours, 48 hours, 1 week, every 3 months for 12 months
Title
Change in Mobility
Description
appearance of teeth mobility after the clinical procedures (record of periodontal pocket depth)
Time Frame
24 hours, 48 hours, 1 week, every 3 months for 12 months
Secondary Outcome Measure Information:
Title
calcific like bridge
Description
measure of the calcific bridge thickness using CBCT
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of dentistry Fayoum University
City
Fayoum
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22339289
Citation
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.
Results Reference
background
PubMed Identifier
31229496
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.
Results Reference
background
Learn more about this trial
PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars
We'll reach out to this number within 24 hrs