NCT06162832

Periodontal Regeneration With Recombinant Human Platelet Derived Growth Factor (rH-PDGF-BB) and Allograft

Evaluation of Clinical and Radiographic Parameters in Bony Defects Treated With Recombinant Human Platelet-derived Growth Factor in Combination With Allograft

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universidad Autonoma de Nuevo Leon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Growth factors are defined as small proteins that trigger a cellular response after binding to cell receptors; Tissue engineering is now clinically applicable in a commercially available system involving the use of recombinant human platelet-derived growth factor. The objective of this study is to evaluate clinical and radiographic parameters in bone defects treated with platelet-derived growth factor in combination with allograft. Our hypothesis: Defects treated with DFDBA and rhPDGF-BB have better clinically and radiographic results that the defects treated with DFDBA and saline solution.

Detailed description

The study will be performed in 30 periodontal defects of 2 and 3 walls. The experimental group will consist of DFDBA placement with rhPDGF-BB and control DFDBA with saline solution. The clinical parameters recorded were Probing deep (PD), clinical attachment level (CAL), recession depth, Index of bleeding and plaque at baseline and at six months. Our universe is patients with periodontitis attending at the clinical in Periodontics at the Autonomous University of Nuevo Leon (UANL) School of Dentistry.

Conditions

• Periodontal Diseases

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Allograft and rHPDGF-BB	At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21)
COMBINATION_PRODUCT	Allograft and Saline solution	This will be used as the control group

Timeline

• Start date: 2024-01-10
• Primary completion: 2024-07-16
• Completion: 2025-01-15
• First posted: 2023-12-08
• Last updated: 2024-05-01

Locations

1 site across 1 country: Mexico

Regulatory

• FDA-regulated drug study