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

F

Future University in Egypt

Status

Completed

Conditions

Periodontal Diseases
Periodontal Bone Loss

Treatments

Procedure: CM
Procedure: L-PRF
Procedure: OFD

Study type

Interventional

Funder types

Other

Identifiers

NCT05496608
Ainshams University

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 patients

Sex

All

Ages

30 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

63 participants in 3 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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