Encapsulated Acellular System From Mesenchymal Stem Cells for Endodontic Treatment of Patients With Apical Periodontitis: Phase I Clinical Trial.

Universidad de los Andes, Chile1 site in 1 country10 target enrollmentDecember 30, 2022

ConditionsPeriapical Periodontitis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Periapical Periodontitis
Sponsor: Universidad de los Andes, Chile
Enrollment: 10
Locations: 1
Primary Endpoint: Regeneration of dental pulp
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the security and efficacy in the administration of encapsulated acellular system derived from Mesenchymal Stem Cells as a novel regenerative endodontic procedure which to promote the pulpar regenration.

Registry

clinicaltrials.gov

Start Date

December 30, 2022

End Date

December 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Universidad de los Andes, Chile

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Systemically healthy patients (ASA I).
•Patient presenting with a maxillary or mandibular incisor/canine and mandibular premolar with mature apex, pulpal necrosis, and apical radiographic evidence of apical periodontitis (PAI ≥2 and CBCTPAI ≥1).
•Patient presents with a tooth that does not respond to electrical and thermal pulp testing.
•Patients with restorable teeth (considering the definition of class A or B, according to Samet and Jotkowitz classification) without the need for a single fine prosthesis (crown) or major restoration.

Exclusion Criteria

•Patients not available for the follow-up period (27 weeks).
•Patients who will undergo orthodontic treatment in the next six months.
•Patients with reports of allergies to any material or medication used in the study.
•Pregnant patients.
•Heavy smokers (more than 10 cigarettes per day).
•Patients with a history of systemic diseases that impair immune function, such as diabetes mellitus, immunodeficiency, leukemia, Addison's and Cushing's disease.
•Patients who have used immunosuppressive drugs or chemotherapy, 3 months before the study. Or that they will be irradiated or undergo chemotherapy.
•Patients who have endodontically treated teeth.
•Patients who have teeth with signs of severe root resorption.
•Patients who have teeth with mobility class III or Dens invaginatus.

Outcomes

Primary Outcomes

Regeneration of dental pulp

Time Frame: 6 months

Patients are expected to have a decrease in the size of the periapical lesion in some of the three dimensions, or an increase of no more than 0.1 mm in one of them, when evaluating radiographic and cone beam computed tomography (CBCT) .