Back to resultsTreatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technque
Primary Purpose
Root Resorption
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
injectable PRF
Sponsored by
About this trial
This is an interventional treatment trial for Root Resorption focused on measuring Pulp revascularization, injectable Platelet rich fibrin, i-PRF, root resorption, CBCT
Eligibility Criteria
Inclusion Criteria:
- patients 13-30 years old
- no sex predilection
- medically free
- Suffering from internal inflammatory root resorption in permanent anterior mature teeth
- associated with or without periapical radiolucency
- no or grade I tooth mobility, and a pocket depth <3 mm
Exclusion Criteria:
- old age
- Medically medically compromised patients
Sites / Locations
- Faculty of dentistry Fayoum University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
injectabl PRF for treatment of internal root resorption
Arm Description
Outcomes
Primary Outcome Measures
change in volumetric size of internal root resorption lesions
Measuring volumetric dimensions of resorption lesion pre and postoperatively using CBCT
Secondary Outcome Measures
change in volumetric size of periapical lesions
Measuring volumetric dimensions of periapical lesion pre and postoperatively using CBCT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04410679
Brief Title
Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technque
Official Title
Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technique: A Clinical Study With Cone Beam Computed Tomography Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 3, 2018 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
May 2, 2020 (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
Currently Endodontics looks forward for regeneration rather than repair. Regenerative endodontic therapy was limited to pulp revascularization of necrotic pulp in immature teeth , followed by mature teeth. Recently pulp revascularization technique by induction of blood clot was applied in the treatment of inflammatory root resorption. So far, no clinical study for management of teeth with inflammatory internal root resorption by using injectable PRF revascularization has been described in the literature. Thus, this is the first clinical attempt to manage inflammatory root resorption in necrotic incisor teeth using injectable PRF regenerative approach.
Detailed Description
13 teeth in a total of 10 patients with inflammatory root resorption will be treated using revascualrization technique, iPRF will be prepared and unjected in the canal after previous canal disinfection with calcium hydroxide for 2-4 weeks. cBCT will be taken preoperative and 12 month follow up period, also clinical and radiographic follow uo will be considered every 3 months for 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Resorption
Keywords
Pulp revascularization, injectable Platelet rich fibrin, i-PRF, root resorption, CBCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
injectabl PRF for treatment of internal root resorption
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
injectable PRF
Intervention Description
blood sample and centrifuged to obtain i-PRF
Primary Outcome Measure Information:
Title
change in volumetric size of internal root resorption lesions
Description
Measuring volumetric dimensions of resorption lesion pre and postoperatively using CBCT
Time Frame
12 months
Secondary Outcome Measure Information:
Title
change in volumetric size of periapical lesions
Description
Measuring volumetric dimensions of periapical lesion pre and postoperatively using CBCT
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients 13-30 years old
no sex predilection
medically free
Suffering from internal inflammatory root resorption in permanent anterior mature teeth
associated with or without periapical radiolucency
no or grade I tooth mobility, and a pocket depth <3 mm
Exclusion Criteria:
old age
Medically medically compromised patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Nageh, Lecturer
Organizational Affiliation
Faculty of dentistry, Fayoum University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of dentistry Fayoum University
City
Fayoum
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Treatment of Internal Inflammatory Root Resorption Using Injectable PRF Revascularization Technque
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