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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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05496608
Enrollment
63
Registered
2022-08-11
Start date
2021-01-01
Completion date
2022-02-01
Last updated
2022-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Bone Loss, Periodontal Diseases

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.

Interventions

PROCEDUREL-PRF

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.

PROCEDUREOFD

Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.

PROCEDURECM

Xenogeneic collagen membranes that are used as barrier membranes in guided tissue regeneration of periodontal defects

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
CEJ to alveolar crest6 monthsmeasures the amount of crystal bone changes
Clinical attachment level6 monthsmeasures the changes in amount of periodontal attachment
CEJ to base of defect6 monthsmeasures the changes in bone defect depth
Gingival index6 monthsmeasures the score of gingival inflammation. Minimum value of 0: denotes absence of inflammation. Maximum value = 3 and denotes severe inflammation
Plaque index6 monthsmeasures 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 depth6 monthsmeasures the reduction in pocket depth

Secondary

MeasureTime frameDescription
VEGF31 daysBiochemical Evaluation of changes in levels of crevicular Vascular endothelial growth factor
PDGF31 daysBiochemical Evaluation of changes in levels of crevicular Platelet Derived Growth Factor -BB

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026