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Rh-PDGF vs EMD for Treatment of Intra-bony Defects

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2027v9
  2. 2 versions Re-verified since Aug 11, 2023, no change to tracked fieldsv7-v8
  3. Primary completion date: May 30, 2023 to Jun 30, 2025
    • Study sites: 2 to 1
    • Study completion date: Dec 30, 2023 to Jun 30, 2025
    v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2022 to Jan 1, 2023
    • Site details revised at 2 of 2 sites
    v5
  5. Start date: Jul 15, 2022 to Oct 1, 2022v4
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  1. Re-verified, no change to tracked fieldsv3
  2. Primary endpoint revisedv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Treatment of intra-bony defects is challenging and requires extensive knowledge of the etiology, anatomy, occlusion, and available biomaterials that can be used to treat this kind of defects. Patients who received scaling and root planing at the college of dental medicine due to periodontal disease, will be screened for inclusion. Only subjects who showed persistent deep probing depth associated with an intrabony defect will be included and will be randomly allocated to one of two treatment groups. One group will be treated using recombinant human platelet derived growth factor (GEM-21) (test) added to allogenic bone graft, second group will be treated using enamel matrix derivatives (EMD) (control) with allograft. Both groups will be treated using the same surgical protocol. Patients will be followed up for a period of 6 months and 12 months, before getting re-evaluated for assessing the effectiveness of the applied therapies.
Trial Details
NCT Number NCT05442034
Lead Sponsor Nova Southeastern University
Conditions
(from sponsor)		 Intrabony Periodontal Defect
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov