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

NCT ID: NCT06162832

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2025-01-15

Brief Summary

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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

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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

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study was conducted in two groups with control and experimental groups which were evaluated during a period of six months with monthly evaluation until the results were obtained.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
It is a triple-blind study, where the operator, the investigator and the statistician have no knowledge of the material placed in the procedure.

Study Groups

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Allograft

Will be used Demineralized cancellous allograft 250-1000um

Group Type ACTIVE_COMPARATOR

Allograft and rHPDGF-BB

Intervention Type COMBINATION_PRODUCT

At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21)

Allograft and Saline solution

Intervention Type COMBINATION_PRODUCT

This will be used as the control group

Saline Solution

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

Group Type SHAM_COMPARATOR

Allograft and Saline solution

Intervention Type COMBINATION_PRODUCT

This will be used as the control group

rhPDGF-BB (GEM21, Lynch Biologics)

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

Group Type EXPERIMENTAL

Allograft and rHPDGF-BB

Intervention Type COMBINATION_PRODUCT

At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21)

Interventions

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Allograft and rHPDGF-BB

At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21)

Intervention Type COMBINATION_PRODUCT

Allograft and Saline solution

This will be used as the control group

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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GEM21 Allograft

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LifeNet Health

INDUSTRY

Sponsor Role collaborator

Lynch Biologics LLC

INDUSTRY

Sponsor Role collaborator

Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role lead

Responsible Party

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Jesus Israel Rodríguez Pulido

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica P Arredondo Muñoz, Resident

Role: PRINCIPAL_INVESTIGATOR

Posgrado De Periodoncia, Universidad autónoma de Nuevo León

Maria Fernanda Treviño Campa, Resident

Role: PRINCIPAL_INVESTIGATOR

Posgrado De Periodoncia, Universidad autónoma de Nuevo León

Gloria Martínez Sandoval, DR

Role: STUDY_DIRECTOR

Posgrado De Periodoncia, Universidad autónoma de Nuevo León

Norma I Rodríguez Franco, DR

Role: STUDY_DIRECTOR

Posgrado De Periodoncia, Universidad autónoma de Nuevo León

Jesús I Rodríguez Pulido, DR

Role: PRINCIPAL_INVESTIGATOR

Posgrado De Periodoncia, Universidad autónoma de Nuevo León

Andrea Ravidà, DDS, MS

Role: STUDY_CHAIR

Department of Periodontics and Preventive Dentistry, University of Pittsburgh School of Dental Medicine

Locations

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Posgrado de Periodoncia, Facultad de Odontología, Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Jesus I Rodriguez Pulido, Dr

Role: CONTACT

52 81 83294000 ext. 3192

Jessica P Arredondo Muñoz, Dr

Role: CONTACT

52 897 104 4619

Facility Contacts

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Jesus I Rodriguez Pulido, Dr

Role: primary

52 81 83294000 ext. 3192

References

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McClain PK. The use of recombinant human platelet-derived growth factor-BB in combination with beta-tricalcium phosphate and rhPDGF-BB in combination with freeze-dried bone allograft plus barrier in two separate complex infrabony defects with long-term follow-up. Clin Adv Periodontics. 2022 Dec;12(4):256-261. doi: 10.1002/cap.10212. Epub 2022 Oct 25.

Reference Type BACKGROUND
PMID: 36281628 (View on PubMed)

Nevins M, Camelo M, Nevins ML, Schenk RK, Lynch SE. Periodontal regeneration in humans using recombinant human platelet-derived growth factor-BB (rhPDGF-BB) and allogenic bone. J Periodontol. 2003 Sep;74(9):1282-92. doi: 10.1902/jop.2003.74.9.1282.

Reference Type BACKGROUND
PMID: 14584860 (View on PubMed)

Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205.

Reference Type RESULT
PMID: 16332231 (View on PubMed)

Nevins M, Kao RT, McGuire MK, McClain PK, Hinrichs JE, McAllister BS, Reddy MS, Nevins ML, Genco RJ, Lynch SE, Giannobile WV. Platelet-derived growth factor promotes periodontal regeneration in localized osseous defects: 36-month extension results from a randomized, controlled, double-masked clinical trial. J Periodontol. 2013 Apr;84(4):456-64. doi: 10.1902/jop.2012.120141. Epub 2012 May 21.

Reference Type RESULT
PMID: 22612364 (View on PubMed)

Other Identifiers

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SPSI-010613

Identifier Type: -

Identifier Source: org_study_id

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