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

NCT06162832 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: SPSI-010613
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Periodontal Regeneration; Grow Factors; intraosseous defects

Outcome Measures

Primary Outcomes (7)

• Probing depth

  The distance from free gingival margin to sulcus depth, ≥4 millimeters (mm)

  Initial and six months after surgery

• Bleeding on probing

  Method to asses gingival inflammation. Gingival health is defined as \< 10% bleeding sites

  Initial and six months after surgery

• Gingival Recession

  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

  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

  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

  O'Leary index is used for assessing oral hygiene skills of the patient

  Initial and six months after surgery

• Radiographic Measurements

  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

Study Arms (3)

Allograft

ACTIVE COMPARATOR

Will be used Demineralized cancellous allograft 250-1000um

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

Saline Solution

SHAM COMPARATOR

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

rhPDGF-BB (GEM21, Lynch Biologics)

EXPERIMENTAL

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

Interventions

Allograft and rHPDGF-BB COMBINATION_PRODUCT

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

Also known as: GEM21, Allograft

Allograft; rhPDGF-BB (GEM21, Lynch Biologics)

Allograft and Saline solution COMBINATION_PRODUCT

This will be used as the control group

Allograft; Saline Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead
• LifeNet Health: collaborator
• Lynch Biologics LLC: collaborator

Study Sites (1)

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

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (4)

• 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.

  PMID: 36281628 BACKGROUND

• 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.

  PMID: 14584860 BACKGROUND

• 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.

  PMID: 16332231 RESULT

• 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.

  PMID: 22612364 RESULT

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Transplantation, Homologous; Becaplermin; Saline Solution

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative; Proto-Oncogene Proteins c-sis; Platelet-Derived Growth Factor; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; DNA-Binding Proteins; Proteins; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

• Jesús I Rodríguez Pulido, DR

  Posgrado De Periodoncia, Universidad autónoma de Nuevo León

  PRINCIPAL INVESTIGATOR

• Andrea Ravidà, DDS, MS

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

  STUDY CHAIR

Central Study Contacts

Jesus I Rodriguez Pulido, Dr

CONTACT

52 81 83294000; jesus.rodriguezpl@uanl.edu.mx

Jessica P Arredondo Muñoz, Dr

CONTACT

52 897 104 4619; jessabh2210@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: It is a triple-blind study, where the operator, the investigator and the statistician have no knowledge of the material placed in the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: December 8, 2023
• Study Start: January 10, 2024
• Primary Completion: July 16, 2024
• Study Completion: January 15, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)