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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162832
• Other study ID #: SPSI-010613
• Status: Recruiting
• Phase: Phase 2
• Start date: January 10, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: April 2024
• Source: Universidad Autonoma de Nuevo Leon
• Contact: Jesus I Rodriguez Pulido, Dr
• Phone: 52 81 83294000
• Email: jesus.rodriguezpl[@]uanl.edu.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 15, 2025
• Est. primary completion date: July 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Combination Product:
• 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

Locations

Country	Name	City	State
Mexico	Posgrado de Periodoncia, Facultad de Odontología, Universidad Autónoma de Nuevo León	Monterrey	Nuevo León

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Autonoma de Nuevo Leon	LifeNet Health, Lynch Biologics LLC

Country where clinical trial is conducted

Mexico, 

References & 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. — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing depth	The distance from free gingival margin to sulcus depth, =4 millimeters (mm)	Initial and six months after surgery
Primary	Bleeding on probing	Method to asses gingival inflammation. Gingival health is defined as < 10% bleeding sites	Initial and six months after surgery
Primary	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
Primary	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
Primary	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
Primary	Plaque control record	O'Leary index is used for assessing oral hygiene skills of the patient	Initial and six months after surgery
Primary	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