Clinical trial NCT06162832: Periodontal Regeneration With Recombinant Human Platelet Derived Growth Factor (rH-PDGF-BB) and Allograft
Official title: Evaluation of Clinical and Radiographic Parameters in Bony Defects Treated With Recombinant Human Platelet-derived Growth Factor in Combination With Allograft
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Periodontal Diseases
Keywords: Periodontal Regeneration
Grow Factors
intraosseous defects
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
Collaborators: name: LifeNet Health
name: Lynch Biologics LLC
First posted: 2023-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Probing depth
timeFrame: Initial and six months after surgery
measure: Bleeding on probing
timeFrame: Initial and six months after surgery
measure: Gingival Recession
timeFrame: Initial and six months after surgery
measure: Clinical Attachment Level
timeFrame: Initial and six months after surgery
measure: Gingival Phenotype
timeFrame: Initial and six months after surgery
measure: Plaque control record
timeFrame: Initial and six months after surgery
measure: Radiographic Measurements
timeFrame: Initial and six months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Posgrado de Periodoncia, Facultad de Odontología, Universidad Autónoma de Nuevo León
state: Nuevo León
Study officials:
affiliation: Posgrado De Periodoncia, Universidad autónoma de Nuevo León
name: Jessica P Arredondo Muñoz, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Posgrado De Periodoncia, Universidad autónoma de Nuevo León
name: Maria Fernanda Treviño Campa, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Posgrado De Periodoncia, Universidad autónoma de Nuevo León
name: Gloria Martínez Sandoval, DR
role: STUDY_DIRECTOR
affiliation: Posgrado De Periodoncia, Universidad autónoma de Nuevo León
name: Norma I Rodríguez Franco, DR
role: STUDY_DIRECTOR
affiliation: Posgrado De Periodoncia, Universidad autónoma de Nuevo León
name: Jesús I Rodríguez Pulido, DR
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Periodontics and Preventive Dentistry, University of Pittsburgh School of Dental Medicine
name: Andrea Ravidà, DDS, MS
role: STUDY_CHAIR
References:
citation: 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.
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.
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 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.
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 randomized, controlled, double-masked clinical trial. J Periodontol. 2013 Apr;84(4):456-64. doi: 10.1902/jop.2012.120141. Epub 2012 May 21.