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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-02-01

Brief Summary

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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.

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Detailed Description

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* 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

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Periodontal Bone Loss Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

* 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.

Study Groups

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Open Flap Debridement

Subjects with infrabony defects had full thickness flap reflection and debridement of periodontal lesion

Group Type PLACEBO_COMPARATOR

OFD

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

L-PRF

Intervention Type PROCEDURE

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.

OFD

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

L-PRF

Intervention Type PROCEDURE

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.

OFD

Intervention Type PROCEDURE

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

CM

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

OFD

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

Intervention Type PROCEDURE

CM

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

Intervention Type PROCEDURE

Other Intervention Names

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Leukocyte platelet rich fibrin Open flap Debridement Collagen membrane

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes