Treatment of Intrabony Defects With L-PRF Membrane With or Without Collagen Membranes
Primary Purpose
Periodontal Bone Loss, Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
L-PRF
OFD
CM
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Bone Loss
Eligibility Criteria
Inclusion Criteria:
- Minimum of one interproximal pocket probing depth of ≥6 mm and/or ≥5 mm CAL after 4 weeks from phase I execution
- 2 or 3 osseous wall interproximal intrabony defects that are ≥3mm in depth
Exclusion Criteria:
- Systemic diseases or conditions that contraindicate periodontal surgeries and/or affect the formed elements of the blood
- Patients who received antibiotic therapy and/or anti-inflammatory drug within the past 6 months
- Vulnerable groups
- Interdental craters and 1 wall osseous defects
- Active periapical pathosis
Sites / Locations
- Ainshams University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Open Flap Debridement
L-PRF
L-PRF + CM
Arm Description
Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion
Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion followed by application of the L-PRF within the bony defect
Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion followed by application of the L-PRF within the bony defect and coverage with collagen xenogeneic membrane
Outcomes
Primary Outcome Measures
Gingival index
measures the score of gingival inflammation. Minimum value of 0: denotes absence of inflammation. Maximum value = 3 and denotes severe inflammation
Plaque index
measures the score of plaque accumulation. Minimum value of 0: denotes absence of plaque on teeth surfaces. Maximum value = 3 and denotes diffuse and abundant plaque accumulation on teeth surfaces
Probing depth
measures the reduction in pocket depth
Clinical attachment level
measures the changes in amount of periodontal attachment
CEJ to base of defect
measures the changes in bone defect depth
CEJ to alveolar crest
measures the amount of crystal bone changes
Secondary Outcome Measures
PDGF
Biochemical Evaluation of changes in levels of crevicular Platelet Derived Growth Factor -BB
VEGF
Biochemical Evaluation of changes in levels of crevicular Vascular endothelial growth factor
Full Information
NCT ID
NCT05496608
First Posted
August 9, 2022
Last Updated
August 22, 2022
Sponsor
Future University in Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05496608
Brief Title
Treatment of Intrabony Defects With L-PRF Membrane With or Without Collagen Membranes
Official Title
Treatment of Periodontal Intrabony Defects With Dense Leukocyte and Platelet-Rich Fibrin (L-PRF) Membrane Alone or in Combination With Collagen Membranes (Randomized Clinical and Biochemical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Future University in Egypt
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
For patients having periodontal intrabony lesions, three treatment modalities were executed to evaluate the effect of protecting Leukocyte rich -Platelet Rich Fibrin harvests (applied in the bony defects) with resorbable collagen membranes. Clinical Outcomes recorded were the Plaque index (PI), Gingival index (GI), probing depth reduction (PD), Clinical attachment level (CAL), and radiographic defect depth changes.
For the biochemical evaluation: levels of PDGF-BB and VEGF obtained from crevicular fluid by Perio-Paper strips were assessed using ELIZA.
Detailed Description
Patients having 2-3 osseous bony wall infrabony periodontal lesions are enrolled in the present study. They have to be free from any systemic disease that contraindicates periodontal surgeries.
Baseline data are obtained including the GI, PI, PD, CAL and preoperative paralleling periapical radiographs.
Full thickness mucoperiosteal flaps are elevated and thorough debridement of the periodontal bony defect is performed.
for OFD group; following debridement and saline irrigation, wound closure proceeds.
for the L-PRF group; L-PRF is prepared and applied within the defect before primary closure.
for the L-PRF + CM: similar procedure like the second group is performed but with an additional protective layer of collagen membrane on top of the defect before wound closure.
from the second day postoperative; Periopaper strips are used to obtain a crevicular fluid sample from the sulcus
At 6 months postoperative: the same baseline clinical measurements are obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Bone Loss, Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The clinical data (Gingival index, Plaque index, PPD, CAL) were collected by a blinded single operator at the university outpatient clinic.
The biochemical analysis: The biochemist received the filter papers with a label for group letter and patient number. She was didn't know which intervention was carried out for any of the samples.
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Flap Debridement
Arm Type
Placebo Comparator
Arm Description
Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion
Arm Title
L-PRF
Arm Type
Active Comparator
Arm Description
Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion followed by application of the L-PRF within the bony defect
Arm Title
L-PRF + CM
Arm Type
Active Comparator
Arm Description
Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion followed by application of the L-PRF within the bony defect and coverage with collagen xenogeneic membrane
Intervention Type
Procedure
Intervention Name(s)
L-PRF
Other Intervention Name(s)
Leukocyte platelet rich fibrin
Intervention Description
a blood sample is obtained from the patient, and centrifuged to prepare a leukocyte platelet rich fibrin harvest that is applied within the derided lesion.
Intervention Type
Procedure
Intervention Name(s)
OFD
Other Intervention Name(s)
Open flap Debridement
Intervention Description
Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.
Intervention Type
Procedure
Intervention Name(s)
CM
Other Intervention Name(s)
Collagen membrane
Intervention Description
Xenogeneic collagen membranes that are used as barrier membranes in guided tissue regeneration of periodontal defects
Primary Outcome Measure Information:
Title
Gingival index
Description
measures the score of gingival inflammation. Minimum value of 0: denotes absence of inflammation. Maximum value = 3 and denotes severe inflammation
Time Frame
6 months
Title
Plaque index
Description
measures the score of plaque accumulation. Minimum value of 0: denotes absence of plaque on teeth surfaces. Maximum value = 3 and denotes diffuse and abundant plaque accumulation on teeth surfaces
Time Frame
6 months
Title
Probing depth
Description
measures the reduction in pocket depth
Time Frame
6 months
Title
Clinical attachment level
Description
measures the changes in amount of periodontal attachment
Time Frame
6 months
Title
CEJ to base of defect
Description
measures the changes in bone defect depth
Time Frame
6 months
Title
CEJ to alveolar crest
Description
measures the amount of crystal bone changes
Time Frame
6 months
Secondary Outcome Measure Information:
Title
PDGF
Description
Biochemical Evaluation of changes in levels of crevicular Platelet Derived Growth Factor -BB
Time Frame
31 days
Title
VEGF
Description
Biochemical Evaluation of changes in levels of crevicular Vascular endothelial growth factor
Time Frame
31 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Minimum of one interproximal pocket probing depth of ≥6 mm and/or ≥5 mm CAL after 4 weeks from phase I execution
2 or 3 osseous wall interproximal intrabony defects that are ≥3mm in depth
Exclusion Criteria:
Systemic diseases or conditions that contraindicate periodontal surgeries and/or affect the formed elements of the blood
Patients who received antibiotic therapy and/or anti-inflammatory drug within the past 6 months
Vulnerable groups
Interdental craters and 1 wall osseous defects
Active periapical pathosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Gamal, P.H.D
Organizational Affiliation
Professor of periodontology
Official's Role
Study Chair
Facility Information:
Facility Name
Ainshams University
City
Cairo
ZIP/Postal Code
4393005
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Treatment of Intrabony Defects With L-PRF Membrane With or Without Collagen Membranes
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