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

Not Applicable

Completed

• Conditions: Periodontal Bone Loss; Periodontal Diseases
• Interventions: Procedure: L-PRF; Procedure: OFD; Procedure: CM

• Registration Number: NCT05496608
• Lead Sponsor: Future University in Egypt

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-11-30
• Study Completion: 2022-02-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-PRF	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
L-PRF	OFD	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
L-PRF + CM	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 and coverage with collagen xenogeneic membrane
Open Flap Debridement	OFD	Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion
L-PRF + CM	OFD	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
L-PRF + CM	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

Primary Outcome Measures

Name	Time	Method
CEJ to alveolar crest	6 months	measures the amount of crystal bone changes
Gingival index	6 months	measures the score of gingival inflammation. Minimum value of 0: denotes absence of inflammation. Maximum value = 3 and denotes severe inflammation
Plaque index	6 months	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	6 months	measures the reduction in pocket depth
CEJ to base of defect	6 months	measures the changes in bone defect depth
Clinical attachment level	6 months	measures the changes in amount of periodontal attachment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ainshams University; 🇪🇬 Cairo, Egypt