Clinical trial

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

Name
SPSI-010613
Description
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.
Trial arms
Trial start
2024-01-10
Estimated PCD
2024-07-16
Trial end
2025-01-15
Status
Recruiting
Phase
Early phase I
Treatment
Allograft and rHPDGF-BB
At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21)
Arms:
Allograft, rhPDGF-BB (GEM21, Lynch Biologics)
Other names:
GEM21, Allograft
Allograft and Saline solution
This will be used as the control group
Arms:
Allograft, Saline Solution
Size
30
Primary endpoint
Probing depth
Initial and six months after surgery
Bleeding on probing
Initial and six months after surgery
Gingival Recession
Initial and six months after surgery
Clinical Attachment Level
Initial and six months after surgery
Gingival Phenotype
Initial and six months after surgery
Plaque control record
Initial and six months after surgery
Radiographic Measurements
Initial and six months after surgery
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'It is a triple-blind study, where the operator, the investigator and the statistician have no knowledge of the material placed in the procedure.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-05-01

1 organization

2 products

1 indication

Product
Allograft