Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05599087

Enrollment

Registered

2022-10-31

Start date

2022-12-30

Completion date

2023-12-30

Last updated

2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periapical Periodontitis

Keywords

mesenchymal stem cells, regenerative procedures, dental pulp, pulp regeneration, allogenic acellular system

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.

Interventions

BIOLOGICALAcellular system

Regenerative Endodontic Procedure Tissue engineering procedure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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. * Patients who have teeth with a history of avulsion-type dentoalveolar trauma. * Patients who have teeth with clinical and/or radiographic evidence of root fracture. * Patients who have teeth that cannot be completely isolated with rubber dam. * Patients who have teeth with more than one root or root canal.

Design outcomes

Primary

Measure	Time frame	Description
Regeneration of dental pulp	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) .

Countries

Chile

Contacts

Primary ContactClaudia Brizuela

clau@cibrizuela.com95349948

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026