Transplantation of Bone Marrow Mesenchymal Stromal Cells for Periodontal Regeneration

Phase 1

• Conditions: Chronic Periodontal Disease; Aggressive Periodontitis

• Registration Number: NCT05975892
• Lead Sponsor: Instituto Venezolano de Investigaciones Cientificas

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 Timeline

• Study Start: 2018-08-30
• Primary Completion: 2022-08-30
• Status Verified: 2023-07
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-27
• Last Update Submitted: 2023-07-27
• Study First Posted: 2023-08-04
• Last Update Posted: 2023-08-04
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 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 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 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 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.

Trial Locations

Locations (1)

Instituto Venezolano de Investigaciones Cientificas; 🇻🇪 Caracas, Miranda, Venezuela