Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration. (RanoKure)

January 16, 2020 updated by: Dra. Claudia Brizuel, Universidad de los Andes, Chile

Encapsulated Mesenchymal Stem Cells for Endodontic Treatment of Permanent Teeth With Apical Lesion: a Controlled Clinical Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a controlled clinical trial designed to evaluate the survival of mature permanent teeth with apical lesion treated with regenerative endodontic procedure (REP) based on encapsulated Mesenchymal Stem Cells in a biological scaffold. The REP will be compared to the conventional endodontic therapy. The REP is based on the use of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial . The study group will use the disinfection protocol, indicated in the clinical considerations for regenerative procedures as recommended by the American Association of Endodontics, using a paste of calcium hydroxide prepared with double-distilled water as intracanal medication, and will be operated with REP using allogeneic stem cells in a scaffold, while the control group will be operated with conventional endodontic therapy alone. This clinical trial pretends to determine the dental survival of the tooth with mature apex and apical lesion, over a period of one year.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Universidad De Los Andes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient inclusion criteria:

  • Age: 16 - 58 years old.
  • Signed the informed consent.
  • Non-smoking.
  • Systemically healthy patients

Tooth inclusion criteria:

  • 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.

Exclusion Criteria:

Patient exclusion criteria:

  • 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.

Tooth exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regenerative Endodontic Procedure (REP)
umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
Procedure: Regenerative Endodontic Procedure
Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with stem cells.
Other Names:
  • REP
  • Tissue engineering procedure
Active Comparator: Conventional Root Canal Treatment
Conventional endodontic procedure
Procedure: Conventional Root Canal Treatment
Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with gutta-percha.
Other Names:
  • Gold standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participats Showing Efficacy (Functionality)
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pulpal Response
Time Frame: baseline, 6 months, 12 months
Change in pulpal response (period 1 year) will be assessed through response to sensitivity tests (cold, hot and electrical test) in teeth treated with regenerative procedure and conventional endodontic treatment during time.
baseline, 6 months, 12 months
Change in Apical Lesion Size
Time Frame: baseline, 6 months, 12 months
Change in apical lesion size will be evaluated by cone beam tomography 6 and 12 months after intervention is completed.
baseline, 6 months, 12 months
Pain to Percussion
Time Frame: baseline, 6 months, 12 months

To compare pain to percussion in a period of 1 year in permanent teeth with mature apex and apical lesion, treated with a regenerative endodontic procedure and conventional endodontic therapy.

This will be monitored 6 and 12 months after the procedure is completed.

Pain to percussion positive: The tooth is tenderness when is softly tapped with handle end of a dental mirror at examination time.

Pain to percussion negative: The tooth is not tenderness when is softly tapped with handle end of a dental mirror at examination time.
baseline, 6 months, 12 months
Numbers of Participants With Adverse Event
Time Frame: 6 months, 12 months
To describe adverse events in a period of 1 year in permanent teeth with mature apex and apical lesion, operated with a regenerative endodontic procedure and conventional endodontic therapy.
6 months, 12 months
Pulp Regeneration
Time Frame: baseline, 6 months, 12 months

To describe the pulp regeneration by means of vitality test using Doppler laser flowmetry (LDF) in a period of 1 year in permanent teeth with mature apex and apical lesion treated with a regenerative endodontic procedure.

The vitality of the teeth was measured by LDF and the perfusion units (PU) percentage of the tooth under study was determined with respect to a healthy control tooth with similar anatomical characteristics from the same patient.
baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de los Andes, Chile

Collaborators

Cells for Cells, Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2016

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

April 6, 2017

Study Record Updates

Last Update Posted (Actual)

January 21, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RPD-8-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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