Treatment of Intrabony Defects With L-PRF Membrane With or Without Collagen Membranes
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)
1 other identifier
interventional
63
1 country
1
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.
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 Jan 2021
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
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 9, 2022
CompletedFirst Posted
Study publicly available on registry
August 11, 2022
CompletedAugust 25, 2022
August 1, 2022
11 months
August 9, 2022
August 22, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
Gingival index
measures the score of gingival inflammation. Minimum value of 0: denotes absence of inflammation. Maximum value = 3 and denotes severe inflammation
6 months
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
6 months
Probing depth
measures the reduction in pocket depth
6 months
Clinical attachment level
measures the changes in amount of periodontal attachment
6 months
CEJ to base of defect
measures the changes in bone defect depth
6 months
CEJ to alveolar crest
measures the amount of crystal bone changes
6 months
Secondary Outcomes (2)
PDGF
31 days
VEGF
31 days
Study Arms (3)
Open Flap Debridement
PLACEBO COMPARATORSubjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion
L-PRF
ACTIVE COMPARATORSubjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion followed by application of the L-PRF within the bony defect
L-PRF + CM
ACTIVE COMPARATORSubjects 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
Interventions
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.
Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.
Xenogeneic collagen membranes that are used as barrier membranes in guided tissue regeneration of periodontal defects
Eligibility Criteria
You may qualify if:
- Minimum of one interproximal pocket probing depth of ≥6 mm and/or ≥5 mm CAL after 4 weeks from phase I execution
- or 3 osseous wall interproximal intrabony defects that are ≥3mm in depth
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ainshams University
Cairo, 4393005, Egypt
Related Publications (1)
Mubarak R, Adel-Khattab D, Abdel-Ghaffar KA, Gamal AY. Adjunctive effect of collagen membrane coverage to L-PRF in the treatment of periodontal intrabony defects: a randomized controlled clinical trial with biochemical assessment. BMC Oral Health. 2023 Sep 4;23(1):631. doi: 10.1186/s12903-023-03332-0.
PMID: 37667213DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ahmed Gamal, P.H.D
Professor of periodontology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- * 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 9, 2022
First Posted
August 11, 2022
Study Start
January 1, 2021
Primary Completion
November 30, 2021
Study Completion
February 1, 2022
Last Updated
August 25, 2022
Record last verified: 2022-08