CompletedNCT05496608Updated Aug 25, 2022

Treatment of Intrabony Defects With L-PRF Membrane With or Without Collagen Membranes

An interventional study of L-PRF and OFD in Periodontal Bone Loss and Periodontal Diseases, sponsored by Future University in Egypt. Completed at 1 site in Egypt. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-25.

Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

Registered 1 year 7 months after the study started (first participant enrolled Jan 2021, registered Aug 2022).

Phase: Not applicable
Study type: Interventional
Enrollment: 63
Allocation: Randomized
Ages: 30 Years to 50 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Periodontal Bone Loss
Periodontal Diseases

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In context

Alveolar Bone Loss

297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.

This study's enrollment of 63 is above the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.

Browse Alveolar Bone Loss studies →

Lead sponsor

Future University in Egypt is the lead sponsor of 97 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 50 Years
Sexes eligible: All
Accepts 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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 63 participants (actual)

Study arms

Placebo comparator
Open Flap Debridement
Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion
Procedure: OFD
Active comparator
L-PRF
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
Procedure: L-PRF · Procedure: OFD
Active comparator
L-PRF + CM
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
Procedure: L-PRF · Procedure: OFD · Procedure: CM

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.
Also known as: Leukocyte platelet rich fibrin
ProcedureOFD
Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.
Also known as: Open flap Debridement
ProcedureCM
Xenogeneic collagen membranes that are used as barrier membranes in guided tissue regeneration of periodontal defects
Also known as: Collagen membrane

What researchers measure

Primary outcomes

Gingival index
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
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
Time frame: 6 months
Probing depth
measures the reduction in pocket depth
Time frame: 6 months
Clinical attachment level
measures the changes in amount of periodontal attachment
Time frame: 6 months
CEJ to base of defect
measures the changes in bone defect depth
Time frame: 6 months
CEJ to alveolar crest
measures the amount of crystal bone changes
Time frame: 6 months

Secondary outcomes

PDGF
Biochemical Evaluation of changes in levels of crevicular Platelet Derived Growth Factor -BB
Time frame: 31 days
VEGF
Biochemical Evaluation of changes in levels of crevicular Vascular endothelial growth factor
Time frame: 31 days

Study locations

1 site

Ainshams University
Cairo, 4393005, Egypt

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05496608
Lead sponsor: Future University in Egypt
Responsible party: Ramy Mubarak Hussein (Principal investigator, Future University in Egypt) — Principal investigator
First posted: Aug 11, 2022
Start date: Jan 1, 2021
Primary completion: Nov 30, 2021
Completion: Feb 1, 2022
Last update: Aug 25, 2022

Study contacts

Ahmed Gamal, P.H.D

study chair · Professor of periodontology

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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