NCT04545307 — drugset

Summary

The purpose of the study is to evaluate the effect of Mesenchymal Stromal Cell (MSC) implantation on pulp and periapical regeneration of immature teeth with pulp necrosis and chronic apical periodontitis. BACKGROUND: * Post-traumatic pulp necrosis prevents root development in children and adolescents. * The multipotent ability of MSC to differentiate into bone-forming cells (osteoblasts) and dentin-forming cells (Odontoblast) has allowed the development of protocols to induce dental pulp regeneration in preclinical models and patients with immature teeth with pulpal necrosis. IMPACT: * Worldwide, post-traumatic pulp necrosis in children and adolescents constitutes a health problem in the endodontic area. * Treatment with MSC would provide an effective therapeutic alternative to patients with pulp necrosis and incomplete root formation. * The possible pulp and periapical regeneration of immature teeth induced by MSC would have a huge impact on the treatment of these patients. Eligibility for EMC implant study Age: 6 to 16 years Sex: Male or Female Healthy volunteers accepted: NO. TREATMENT GROUPS: In the present study, the implantation of MSC will be performed in patients with immature teeth with pulpal necrosis with apical periodontitis, who will receive the appropriate endodontic treatment (according to the guidelines of the American Association of Endodontics) and implantation of allogeneic BM-MSC . This group will be compared with the history made in the Postgraduate Endodontics of the Universidad Central de Venezuela (UCV) and with international case series made by revascularization. Clinical follow-up of each patient: 1. Clinical controls (facial evaluation, gingival evaluation, apical palpation, horizontal and vertical percussion, cold and heat sensitivity tests) will be carried out on days 0, 7, 30, 90, 180 and 364. Additionally, a clinical evaluation will be carried out at the two years post-implantation of MSC. 2. Radiological controls will be carried out on days 0, 7, 30, 90, 180 and 364. Additionally, they will be carried out two years post-implantation of MSC. 3. A tomographic evaluation will be performed when was evident periapical repair in a periapical radiograph. To measure root formation, root canal narrowing and verification the periapical repair in 3D.

Timeline

Start: 2019-11-27
Primary completion: 2019-12-27
Completion: 2020-01-27

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MSC-Endo	Unknown	75000 cells	Other
Subject	Mesenchymal stem cell	Cell therapy	75000 cells	Other
Background	Platelet Rich Plasma	Other / unclassified	—	Other

Transplantation of Allogeneic MSC in Patients With Pulp Necrosis and Chronic Apical Periodontitis

Summary

Timeline

Publications

Drugs

Indications