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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Combination Product: Allograft and rHPDGF-BB
* Combination Product: Allograft and Saline solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allograft<br>Will be used Demineralized cancellous allograft 250-1000um | Combination Product: Allograft and rHPDGF-BB<br>* At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21)<br>* Other names: Allograft;Combination Product: Allograft and Saline solution<br>* This will be used as the control group<br>|
| Sham Comparator: Saline Solution<br>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<br>* This will be used as the control group<br>|
| Experimental: rhPDGF-BB (GEM21, Lynch Biologics)<br>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<br>* At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21)<br>* Other names: Allograft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | Initial and six months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal Regeneration, Grow Factors, intraosseous defects