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)

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Periodontal Bone Loss
• Intervention / Treatment: Procedure: OFD; Procedure: L-PRF; Procedure: CM

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 4393005
    • Ainshams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Open Flap Debridement; Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion	Procedure: OFD; Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.; Other Names: Open flap Debridement
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: OFD; Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.; Other Names: Open flap Debridement; Procedure: L-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.; Other Names: Leukocyte platelet rich fibrin
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: OFD; Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.; Other Names: Open flap Debridement; Procedure: L-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.; Other Names: Leukocyte platelet rich fibrin; Procedure: CM; Xenogeneic collagen membranes that are used as barrier membranes in guided tissue regeneration of periodontal defects; Other Names: Collagen membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PDGF	Biochemical Evaluation of changes in levels of crevicular Platelet Derived Growth Factor -BB	31 days
VEGF	Biochemical Evaluation of changes in levels of crevicular Vascular endothelial growth factor	31 days

Collaborators and Investigators

• Sponsor: Future University in Egypt
• Investigators: Study Chair: Ahmed Gamal, P.H.D, professor of periodontology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Periodontal Diseases; Alveolar Bone Loss
• Other Study ID Numbers: Ainshams University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No