drugset / Trial / NCT05442034

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

NCT05442034 ↗

Phase 1/2 Recruiting 36 enrolled Nova Southeastern University
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2023-01-01
Primary completion
2027-06-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Enamel Matrix Derivatives Protein / enzyme biologic — —
Subject recombinant human platelet derived growth factor Protein / enzyme biologic — —

Indications