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

NCT04545307 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-09-16

No results posted yet for this study

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.

Conditions

  • Pulp Necroses
  • Apical Periodontitis

Interventions

BIOLOGICAL

Allogenic transplant of BM-MSC in a root canal from patients with immature apexes and pulpar necrosis and apical periodontitis

The implant of BM-MSC/MSC-Endo/PRP in a clean and shaped root canal from patients with immature apexes and pulpal necroses and apical periodontitis

Sponsors & Collaborators

  • Instituto Venezolano de Investigaciones Cientificas

    collaborator OTHER

  • Universidad Central de Venezuela

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Venezuela

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04545307 on ClinicalTrials.gov