Aggressive Periodontitis, Chronic Periodontal Disease
Conditions
Keywords
Mesenchymal stromal cells, Periodontal regeneration, Bone regeneration, Periodontitis
Brief summary
The goal of this study is to evaluate the capacity of allogeneic bone marrow mesenchymal stromal cells (MSC) to induce bone regeneration in patients with periodontal disease. MSC cultured are loaded on a collagen scaffold, included into autologous platelet rich plasma clot and implanted in the bone defect.
Detailed description
The clinical protocol is designed to evaluate the bone regeneration capacity of allogeneic MSCs for the treatment of patients with chronic or aggressive periodontal disease. Patients with either a 2- or 3-wall intrabony defects are included in this study. A bioengineering construct, constituted by allogeneic MSCs and a collagen scaffold, is incorporated into platelet rich plasma (PRP) clot, which is implanted at the bone defect site. Follow up of treated tooth are assessed by clinical evaluation, intraoral radiography and cone-beam CT.
Interventions
BIOLOGICALTransplantation of allogeneic MSCs in periodontal disease
Oral surgery is performed in patients with periodontal disease, under local anesthesia. An incision will be made on the periodontal lesion, A full-thickness flap is elevated on both the buccal and lingual areas and the inner epithelium of the flap removed. Granulation tissue is removed from bone defect area, and a root planning is performed. MSC construct is placed around the bone defect and a collagen membrane is used to cover and close off the bone defect site. The flap will be repositioned and the wound closed by a suture
Sponsors
Instituto Venezolano de Investigaciones Cientificas
Universidad Central de Venezuela
Hospital Central Dr. Plácido D. Rodriguez Rivero, San Felipe, Yaracuy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Medical healthy * Minimum age of 18 years old * Diagnosis of chronic or aggressive periodontitis * Vertical intrabony defects of three or two walls * PPD \>= 5 mm * Radiographic evidence of alveolar bone loss of at least 3 mm * Minimim 20 teeth presents in mouth. * Informed consent of the patient
Exclusion criteria
* Smoking * Pregnancy or lactating * Receiving immunosuppressive drugs, anticoagulants, antibiotics or analgesic drugs * Diabetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in bone density | Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation | Changes in the density of the periodontal bone defect will be detected by Cone beam Tomography |
| Change in probing pocket depth (PPD) | Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation | The distance from the gingival margin to the bottom of the gingival sulcus/pocket, is measured by means of periodontal probe. |
| Gingival recession (GR) | Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation | Exposure of the tooth through apical migration of the gingiva will be recorded as the distance in millimeters from the CEJ to the gingival margin |
| Change in clinical attachment level (CAL) | Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation | Expressed as the distance in millimeters from the cemento-enamel junction (CEJ) to the bottom of the probable gingival/periodontal pocket. |
| Change in Tooth Mobility (TM) | Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation | Changes from baseline in tooth mobility will be recorded. |
| Change in bone depth | Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation | The vertical bone defects will be assessed by X-rays. The postoperative depth of the intrabony defect will be calculated from the distance between the cemento-enamel junction and the bone crest on the preoperative and postoperative radiographs at the same magnification. |
Countries
Venezuela
Outcome results
None listed