NCT05599087

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

10 months

First QC Date

October 25, 2022

Last Update Submit

October 25, 2022

Conditions

Periapical Periodontitis

Keywords

mesenchymal stem cellsregenerative proceduresdental pulppulp regenerationallogenic acellular system

Outcome Measures

Primary Outcomes (1)

  • Regeneration of dental pulp

    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) .

    6 months

Study Arms (1)

Acellular system

EXPERIMENTAL

Regenerative Endodontic Procedure (REP) the acellular system derived from umbilical cord-derived mesenchymal stem cells encapsulated in a platelet-poor plasma-derived biomaterial.

Biological: Acellular system

Interventions

Acellular systemBIOLOGICAL

Regenerative Endodontic Procedure Tissue engineering procedure

Acellular system

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de los Andes

Las Condes, Santiago Metropolitan, 7620157, Chile

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Central Study Contacts

Claudia Brizuela

CONTACT

95349948clau@cibrizuela.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 31, 2022

Study Start

December 30, 2022

Primary Completion

October 30, 2023

Study Completion

December 30, 2023

Last Updated

October 31, 2022

Record last verified: 2022-10

Locations

CL(1)