- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04330768
Platelet Rich Fibrin(PRF) Injection for Treatment of Dental Pulp Exposure:Randomized Clinical Trial
March 31, 2020 updated by: Dina mounir elkady, Cairo University
Platelet Rich Fibrin(PRF) Versus Pulp Capping in Treatment of Dental Pulp Exposure:Randomized Clinical Trial
platelet rich fibrin(PRF) obtained from patient from patient blood sample (before start of treatment)is injected in the site of exposure of exposure(intervention group) control group will receive normal pulp capping procedure by MTA follow up will be one year
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
intervention group:patient with deep caries lesion ,free from sign and symptoms of irreversible pulpitis the blood sample will be taken before the beginning of dental treatment..PRF will be obtained by blood centrifugal and injected in the site of exposure covered by glass ionomer restoration control group: patient with same condition will receive pulp capping procedure by MTA followed by glass ionomer restoration
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- deep carious lesion- no sign of irreversible pulpitis
Exclusion Criteria:
- old age- periapical lesion-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PRF
|
PRF is injected in the site of exposure
|
Active Comparator: MTA
|
conventional pulp capping procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pulp vitality
Time Frame: After 1 year
|
no sign of irreversible pulpitis or pulpal necrosis
|
After 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2021
Primary Completion (Anticipated)
March 1, 2022
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
March 30, 2020
First Submitted That Met QC Criteria
March 31, 2020
First Posted (Actual)
April 1, 2020
Study Record Updates
Last Update Posted (Actual)
April 2, 2020
Last Update Submitted That Met QC Criteria
March 31, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0555
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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