Skip to main content
OpenTrials
Completed

NCT Number: NCT05496608

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ainshams University

Cairo, 4393005, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-PRF

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.

Other names: Leukocyte platelet rich fibrin

OFD

Procedure

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

Other names: Open flap Debridement

CM

Procedure

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

Other names: Collagen membrane

Primary outcomes

  1. Gingival index

    Time frame: 6 months

    measures the score of gingival inflammation. Minimum value of 0: denotes absence of inflammation. Maximum value = 3 and denotes severe inflammation

  2. Plaque index

    Time frame: 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

  3. Probing depth

    Time frame: 6 months

    measures the reduction in pocket depth

  4. Clinical attachment level

    Time frame: 6 months

    measures the changes in amount of periodontal attachment

  5. CEJ to base of defect

    Time frame: 6 months

    measures the changes in bone defect depth

  6. CEJ to alveolar crest

    Time frame: 6 months

    measures the amount of crystal bone changes

Secondary outcomes

  1. PDGF

    Time frame: 31 days

    Biochemical Evaluation of changes in levels of crevicular Platelet Derived Growth Factor -BB

  2. VEGF

    Time frame: 31 days

    Biochemical Evaluation of changes in levels of crevicular Vascular endothelial growth factor

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 11, 2022
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.