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

April 29, 2024 updated by: Jesus Israel Rodríguez Pulido, Universidad Autonoma de Nuevo Leon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Posgrado de Periodoncia, Facultad de Odontología, Universidad Autónoma de Nuevo León
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Allograft
Will be used Demineralized cancellous allograft 250-1000um
Combination product: Allograft and rHPDGF-BB
At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21)
Other Names:
  • Allograft
  • GEM21
Combination product: Allograft and Saline solution
This will be used as the control group
Sham Comparator: Saline Solution
The saline solution will be used for hydrate the bone graft 20 minutes before the placement at the defect
Combination product: Allograft and Saline solution
This will be used as the control group
Experimental: rhPDGF-BB (GEM21, Lynch Biologics)
The rhPDGF-BB will be used for hydrate the bone graft 20 minutes before the placement at the defect
Combination product: Allograft and rHPDGF-BB
At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21)
Other Names:
  • Allograft
  • GEM21

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: Initial and six months after surgery
The distance from free gingival margin to sulcus depth, ≥4 millimeters (mm)
Initial and six months after surgery
Bleeding on probing
Time Frame: Initial and six months after surgery
Method to asses gingival inflammation. Gingival health is defined as < 10% bleeding sites
Initial and six months after surgery
Gingival Recession
Time Frame: Initial and six months after surgery
The distance from the soft tissue (gingiva or alveolar mucosa) margin to cemento-enamel junction, ≥1 millimeters (mm)
Initial and six months after surgery
Clinical Attachment Level
Time Frame: Initial and six months after surgery
The distance from the cemento-enamel junction to the tip of a periodontal probe during periodontal diagnostic probing, ≥2 mm (millimeters)
Initial and six months after surgery
Gingival Phenotype
Time Frame: Initial and six months after surgery

Gingival phenotype is determined by gingival thickness and keratinized tissue width.

Probe visible: thin (≤1 mm). Probe not visible: thick (>1mm).
Initial and six months after surgery
Plaque control record
Time Frame: Initial and six months after surgery
O'Leary index is used for assessing oral hygiene skills of the patient
Initial and six months after surgery
Radiographic Measurements
Time Frame: Initial and six months after surgery

Cemento-enamel junction (CEJ)-Defect Base (DB): The distance of the cementoenamel junction at the base of the defect.

Cemento-enamel junction (CEJ)-Bone crest (BC): The distance of the cemento-enamel junction to the crest of bone.

Cemento-enamel junction (CEJ)- Root apex (RA): The distance of the cemento-enamel junction to root apex.

Lineal Bone Growth (LBG) = CEJ to base of defect at baseline - CEJ to base of defect at 6 months.

%BF: Percent bone fill was calculated by dividing LBG by the depth of the original bone defect
Initial and six months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Nuevo Leon

Collaborators

LifeNet Health
Lynch Biologics LLC

Investigators

  • Principal Investigator: Jessica P Arredondo Muñoz, Resident, Posgrado De Periodoncia, Universidad autónoma de Nuevo León
  • Principal Investigator: Maria Fernanda Treviño Campa, Resident, Posgrado De Periodoncia, Universidad autónoma de Nuevo León
  • Study Director: Gloria Martínez Sandoval, DR, Posgrado De Periodoncia, Universidad autónoma de Nuevo León
  • Study Director: Norma I Rodríguez Franco, DR, Posgrado De Periodoncia, Universidad autónoma de Nuevo León
  • Principal Investigator: Jesús I Rodríguez Pulido, DR, Posgrado De Periodoncia, Universidad autónoma de Nuevo León
  • Study Chair: Andrea Ravidà, DDS, MS, Department of Periodontics and Preventive Dentistry, University of Pittsburgh School of Dental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Estimated)

July 16, 2024

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPSI-010613

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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