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Active, not recruiting Early Phase 1

The Present Study Was Performed to Evaluate the Efficacy of Lyophilized-PRF in Treatment of Periodontal Intra-bony Defects

NCT06625528 · tracked via the Priya Life Science Egypt tracker
Phase
Early Phase 1
Started
2023-11-19
Last updated
2024-10-15

Condition(s) studied

Treatment of Periodontal Intra-bony Defects

Investigational drug(s) / intervention(s)

open flap debridement

open flap debridement: does lyophilized platelet rich fibrin combined with open flap debridement or combination of open flap debridement, lyophilized platelet rich fibrin and nano-crystalline hydroxyapatite bone substitute can add benefits to open flap debridement alone or not

Study summary

The present study will be performed to evaluate the efficacy of lyophilized platelet-rich fibrin alone and combined with nanocrystalline hydroxyapatite in treatment of periodontal intra-bony defects through:

1. Primary outcomes:

* The clinical parameters including: Probing pocket depth (PPD) reduction and clinical attachment level (CAL) gain.
* The radiographic parameters including: Marginal bone level (MBL), bone-defect fill.
2. Secondary outcome: The level of BMP-2 in Gingival crevicular fluid (GCF).

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * All periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm. * 2- or 3-wall intra-bony interproximal defect with depth ≥3 mm, a width of ≥3 mm at its most coronal part and 45-55-degree angulation will be selected in order to reduce defect variability. * All patients will be free from any systemic diseases according to the American Dental Academy general guidelines for referring dental patients to specialists and other care settings Exclusion Criteria: * Any patients with any systemic condition that contraindicate any surgical intervention. * Pregnant or lactating females, smokers, or alcoholic patients. * Patients with intra-bony defects received drugs that affect bone turnover such as (chemotherapy and radiotherapy). * History of periodontal therapy and antibiotic administration in the last 6 months. * Patients taking any medicine which may affect the function of platelet (i.e., aspirin) in the previous 3 months. * Miller grade II or greater mobility, furcation involvement as well as one-wall defects and interdental craters. * Patients with unacceptable oral hygiene after the re-evaluation of phase I therapy.

Primary outcome measure(s)

  • radiographic parameters — baseline, 3, 6, and 9 months after treatment
    The radiographic parameters including: Bone-defect fill in mm.
  • clinical parameters — baseline, 3, 6, and 9 months after treatment.
    The clinical parameters including: Clinical attachment level (CAL) gain in mm.

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dental Medicine, Al- Azhar University, Asyut Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06625528 on ClinicalTrials.gov ↗ ← All trials in Egypt