CClinicalTrials.gg
Status unknownNCT05599087Updated Oct 31, 2022

Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration

A Phase 1 interventional study of Acellular system in Periapical Periodontitis, sponsored by Universidad de los Andes, Chile. Status unknown at 1 site in Chile. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-10-31.

Sponsored by Universidad de los Andes, Chile · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Periapical Periodontitis

Keywords

  • mesenchymal stem cells
  • regenerative procedures
  • dental pulp
  • pulp regeneration
  • allogenic acellular system
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's planned enrollment of 10 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Universidad de los Andes, Chile is the lead sponsor of 44 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Acellular system

    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

  • BiologicalAcellular system

    Regenerative Endodontic Procedure Tissue engineering procedure

06

What researchers measure

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) .

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Universidad de los Andes
    Las Condes, Region Metropolitana 7620157, Chile
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05599087
Lead sponsor
Universidad de los Andes, Chile
Collaborators
Cells for Cells
Responsible party
Sponsor
First posted
Oct 31, 2022
Start date
Dec 30, 2022 (estimated)
Primary completion
Oct 30, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Oct 31, 2022

Study contacts

Claudia Brizuela
Contact
clau@cibrizuela.com
95349948

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion