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| Name | Class |
|---|---|
| LifeNet Health | INDUSTRY |
| Lynch Biologics LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allograft | Active Comparator | Will be used Demineralized cancellous allograft 250-1000um |
|
| Saline Solution | Sham Comparator | The saline solution will be used for hydrate the bone graft 20 minutes before the placement at the defect |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allograft and rHPDGF-BB | Combination Product | At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesus I Rodriguez Pulido, Dr | Contact | 52 81 83294000 | 3192 | jesus.rodriguezpl@uanl.edu.mx |
| Jessica P Arredondo Muñoz, Dr | Contact | 52 897 104 4619 | jessabh2210@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Posgrado de Periodoncia, Facultad de Odontología, Universidad Autónoma de Nuevo León | Recruiting | Monterrey | Nuevo León | 64460 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36281628 | Background | 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. | |
| 14584860 |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014184 | Transplantation, Homologous |
| D000077214 | Becaplermin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D020574 | Proto-Oncogene Proteins c-sis |
| D010982 | Platelet-Derived Growth Factor |
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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.
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It is a triple-blind study, where the operator, the investigator and the statistician have no knowledge of the material placed in the procedure.
|
| Allograft and Saline solution | Combination Product | This will be used as the control group |
|
| Initial and six months after surgery |
| 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 |
| 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. |
| 16332231 | Result | 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. |
| 22612364 | 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. |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004268 | DNA-Binding Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |