Periodontal Regeneration With Recombinant Human Platelet Derived Growth Factor (rH-PDGF-BB) and Allograft
- Conditions
- Periodontal Diseases
- Interventions
- Combination Product: Allograft and rHPDGF-BBCombination Product: Allograft and Saline solution
- Registration Number
- NCT06162832
- Lead Sponsor
- Universidad Autonoma de Nuevo Leon
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- Patients undergoing bisphosphonate therapy
- Furcation defects
- Patients with evidence of blood dyscrasias.
- Pregnant patient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Allograft Allograft and Saline solution Will be used Demineralized cancellous allograft 250-1000um Allograft Allograft and rHPDGF-BB Will be used Demineralized cancellous allograft 250-1000um Saline Solution Allograft and Saline solution The saline solution will be used for hydrate the bone graft 20 minutes before the placement at the defect rhPDGF-BB (GEM21, Lynch Biologics) Allograft and rHPDGF-BB The rhPDGF-BB will be used for hydrate the bone graft 20 minutes before the placement at the defect
- Primary Outcome Measures
Name Time Method Gingival Recession Initial and six months after surgery The distance from the soft tissue (gingiva or alveolar mucosa) margin to cemento-enamel junction, ≥1 millimeters (mm)
Radiographic Measurements Initial and six months after surgery 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 defectBleeding on probing Initial and six months after surgery Method to asses gingival inflammation. Gingival health is defined as \< 10% bleeding sites
Clinical Attachment Level Initial and six months after surgery The distance from the cemento-enamel junction to the tip of a periodontal probe during periodontal diagnostic probing, ≥2 mm (millimeters)
Gingival Phenotype Initial and six months after surgery Gingival phenotype is determined by gingival thickness and keratinized tissue width.
Probe visible: thin (≤1 mm). Probe not visible: thick (\>1mm).Probing depth Initial and six months after surgery The distance from free gingival margin to sulcus depth, ≥4 millimeters (mm)
Plaque control record Initial and six months after surgery O'Leary index is used for assessing oral hygiene skills of the patient
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Posgrado de Periodoncia, Facultad de Odontología, Universidad Autónoma de Nuevo León
🇲🇽Monterrey, Nuevo León, Mexico