Periodontal Regeneration With Recombinant Human Platelet Derived Growth Factor (rH-PDGF-BB) and Allograft
NCT ID: NCT06162832
Last Updated: 2024-05-01
Study Results
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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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2024-01-10
2025-01-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Allograft
Will be used Demineralized cancellous allograft 250-1000um
Allograft and rHPDGF-BB
At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21)
Allograft and Saline solution
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
Allograft and Saline solution
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
Allograft and rHPDGF-BB
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)
Allograft and Saline solution
This will be used as the control group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Furcation defects
* Patients with evidence of blood dyscrasias.
* Pregnant patient
18 Years
ALL
Yes
Sponsors
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LifeNet Health
INDUSTRY
Lynch Biologics LLC
INDUSTRY
Universidad Autonoma de Nuevo Leon
OTHER
Responsible Party
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Jesus Israel Rodríguez Pulido
Doctor
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
Other Identifiers
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SPSI-010613
Identifier Type: -
Identifier Source: org_study_id
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