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

Universidad Autonoma de Nuevo Leon

Status and phase: Enrolling; Phase 2

Conditions: Periodontal Diseases

Treatments: Combination Product: Allograft and Saline solution; Combination Product: Allograft and rHPDGF-BB

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06162832

SPSI-010613

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of periodontitis
• Infrabony defects of 2 walls, 3 walls and combined defects
• Patients ASA (American Society of Anesthesiologists) I and II
• Patients who smoke less than 10 cigarettes

Exclusion criteria

• Patients undergoing bisphosphonate therapy
• Furcation defects
• Patients with evidence of blood dyscrasias.
• Pregnant patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Allograft

Active Comparator group

Description:

Will be used Demineralized cancellous allograft 250-1000um

Treatment:

Combination Product: Allograft and rHPDGF-BB

Combination Product: Allograft and Saline solution

Saline Solution

Sham Comparator group

Description:

The saline solution will be used for hydrate the bone graft 20 minutes before the placement at the defect

Treatment:

Combination Product: Allograft and Saline solution

rhPDGF-BB (GEM21, Lynch Biologics)

Experimental group

Description:

The rhPDGF-BB will be used for hydrate the bone graft 20 minutes before the placement at the defect

Treatment:

Combination Product: Allograft and rHPDGF-BB