MedTrace Logo

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

NCT06162832 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-05-01

No results posted yet for this study

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.

Conditions

  • Periodontal Diseases

Interventions

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

Sponsors & Collaborators

  • LifeNet Health

    collaborator INDUSTRY

  • Lynch Biologics LLC

    collaborator INDUSTRY

  • Universidad Autonoma de Nuevo Leon

    lead OTHER

Principal Investigators

  • Jessica P Arredondo Muñoz, Resident · Posgrado De Periodoncia, Universidad autónoma de Nuevo León

  • Maria Fernanda Treviño Campa, Resident · Posgrado De Periodoncia, Universidad autónoma de Nuevo León

  • Gloria Martínez Sandoval, DR · Posgrado De Periodoncia, Universidad autónoma de Nuevo León

  • Norma I Rodríguez Franco, DR · Posgrado De Periodoncia, Universidad autónoma de Nuevo León

  • Jesús I Rodríguez Pulido, DR · Posgrado De Periodoncia, Universidad autónoma de Nuevo León

  • Andrea Ravidà, DDS, MS · Department of Periodontics and Preventive Dentistry, University of Pittsburgh School of Dental Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-10
Primary Completion
2024-07-16
Completion
2025-01-15
FDA Drug
Yes

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06162832 on ClinicalTrials.gov