Transplantation of Bone Marrow Mesenchymal Stromal Cells for Bone Regeneration in Periodontal Disease
Trial Snapshot
- Phase
- Phase 1
- Status
- Enrolling By Invitation
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in probing pocket depth (PPD)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Pregnancy or lactating
- •Receiving immunosuppressive drugs, anticoagulants, antibiotics or analgesic drugs
- •Diabetics
Arms & Interventions
Allogeneic MSCs transplantation in periodontal disease
Allogeneic MSC harvested and cultured in osteogenic medium are seeded on collagen scaffold, mixed with autologous platelet rich plasma clot. The MSCs construct (MSCs/Coll/PRP clot) is implanted in the bone defect.
Intervention: Transplantation of allogeneic MSCs in periodontal disease (Biological)
Outcomes
Primary Outcomes
Change in probing pocket depth (PPD)
Time Frame: 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.
Change in clinical attachment level (CAL)
Time Frame: 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 bone density
Time Frame: 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 Tooth Mobility (TM)
Time Frame: Follow-up includes evaluation at 3, 6, 9 and 12 months post-transplantation
Changes from baseline in tooth mobility will be recorded.
Gingival recession (GR)
Time Frame: 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 bone depth
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dylana Diaz Solano
Clinical Investigator
Instituto Venezolano de Investigaciones Cientificas