NCT03102879

Brief Summary

To compare the dental survival in a period of one year of mature permanent teeth with apical lesion following the administration of encapsulated Mesenchymal Stem Cells under a regenerative endodontic procedure and a conventional root canal treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 23, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 21, 2020

Completed
Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

March 21, 2017

Results QC Date

December 10, 2019

Last Update Submit

January 16, 2020

Conditions

Periapical Periodontitis

Keywords

mesenchymal stem cellsregenerative procedurestissue engineeringregenerative endodonticscaffoldcell encapsulationdental pulppulp regenerationplasma-derived biomaterialallogenic stem cellsmesenchymal stromal cellsadult stem cellsumbilical cord stem cells

Outcome Measures

Primary Outcomes (1)

  • Number of Participats Showing Efficacy (Functionality)

    Efficacy (functionality) was defined when one year after the intervention, the treated tooth remains in the mouth, without pain to percussion test and with apical bone lesion of equal size in the three senses of space or a decrease in some of them or no more than 0.1 mm increase of one of them.

    12 months

Secondary Outcomes (5)

  • Change in Pulpal Response

    baseline, 6 months, 12 months

  • Change in Apical Lesion Size

    baseline, 6 months, 12 months

  • Pain to Percussion

    baseline, 6 months, 12 months

  • Numbers of Participants With Adverse Event

    6 months, 12 months

  • Pulp Regeneration

    baseline, 6 months, 12 months

Study Arms (2)

Regenerative Endodontic Procedure (REP)

EXPERIMENTAL

umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.

Procedure: Regenerative Endodontic Procedure

Conventional Root Canal Treatment

ACTIVE COMPARATOR

Conventional endodontic procedure

Procedure: Conventional Root Canal Treatment

Interventions

Regenerative Endodontic ProcedurePROCEDURE

Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with stem cells.

Also known as: REP, Tissue engineering procedure
Regenerative Endodontic Procedure (REP)
Conventional Root Canal TreatmentPROCEDURE

Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with gutta-percha.

Also known as: Gold standard treatment
Conventional Root Canal Treatment

Eligibility Criteria

Age16 Years - 58 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: 16 - 58 years old.
  • Signed the informed consent.
  • Non-smoking.
  • Systemically healthy patients
  • Upper and lower incisors, upper and lower canines and lower premolars teeth with mature apex and apical lesion (greater than 2 PAI and 1 CBCTPAI).
  • Teeth that do not response to both electrical and thermal pulp test
  • Teeth that can be restored (as defined by Class A or Class B using Samet and Jotkowitz classification) without the need of a stainless steel crown.

You may not qualify if:

  • Patients without a phone number for contact during the study.
  • Subjects not available for follow up period (12 months).
  • Patients who are or will undergo orthodontic treatment over the next 12 months.
  • Patients with an allergy to any material or drug used in the study.
  • Patients who are pregnant or lactating.
  • Patients with a history of systemic diseases that alter immune function, such as diabetes mellitus, immunodeficiency, leukemia, Addison's disease and Cushing.
  • Patients who have used immunosuppressive drugs or chemotherapy, 3 months before the study.
  • Endodontically treated teeth
  • Teeth with signs of severe root resorption.
  • Teeth with mobility class III or Dens invaginatus.
  • Teeth with avulsion history and conservation in a dry extraoral medium for more than 1 hour.
  • Teeth with clinical and / or radiographic evidence of root fracture.
  • Teeth that can not be absolutely isolated with rubber dam. . 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

Santiago, Chile

Location

Related Publications (1)

  • Brizuela C, Meza G, Urrejola D, Quezada MA, Concha G, Ramirez V, Angelopoulos I, Cadiz MI, Tapia-Limonchi R, Khoury M. Cell-Based Regenerative Endodontics for Treatment of Periapical Lesions: A Randomized, Controlled Phase I/II Clinical Trial. J Dent Res. 2020 May;99(5):523-529. doi: 10.1177/0022034520913242. Epub 2020 Mar 23.

    PMID: 32202965DERIVED

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Results Point of Contact

Title
Claudia Brizuela
Organization
Universidad de los Andes
clau@cibrizuela.com
56 2 26181166

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 interventions: 1. Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. 2. Endodontic treatment with inert product gutapercha.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Dental Surgery

Study Record Dates

First Submitted

March 21, 2017

First Posted

April 6, 2017

Study Start

September 23, 2016

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

January 21, 2020

Results First Posted

January 21, 2020

Record last verified: 2020-01

Locations

CL(1)