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

Primary Purpose

Periapical Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Regenerative Endodontic Procedure
Conventional Root Canal Treatment
Sponsored by
Universidad de los Andes, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Periodontitis focused on measuring mesenchymal stem cells, regenerative procedures, tissue engineering, regenerative endodontic, scaffold, cell encapsulation, dental pulp, pulp regeneration, plasma-derived biomaterial, allogenic stem cells, mesenchymal stromal cells, adult stem cells, umbilical cord stem cells

Eligibility Criteria

16 Years - 58 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad de los Andes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regenerative Endodontic Procedure (REP)

Conventional Root Canal Treatment

Arm Description

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

Conventional endodontic procedure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Pulpal Response
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.
Change in Apical Lesion Size
Change in apical lesion size will be evaluated by cone beam tomography 6 and 12 months after intervention is completed.
Pain to Percussion
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.
Numbers of Participants With Adverse Event
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.
Pulp Regeneration
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.

Full Information

First Posted
March 21, 2017
Last Updated
January 16, 2020
Sponsor
Universidad de los Andes, Chile
Collaborators
Cells for Cells, Chile
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1. Study Identification

Unique Protocol Identification Number
NCT03102879
Brief Title
Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration.
Acronym
RanoKure
Official Title
Encapsulated Mesenchymal Stem Cells for Endodontic Treatment of Permanent Teeth With Apical Lesion: a Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 23, 2016 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de los Andes, Chile
Collaborators
Cells for Cells, Chile

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis
Keywords
mesenchymal stem cells, regenerative procedures, tissue engineering, regenerative endodontic, scaffold, cell encapsulation, dental pulp, pulp regeneration, plasma-derived biomaterial, allogenic stem cells, mesenchymal stromal cells, adult stem cells, umbilical cord stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 interventions: Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. Endodontic treatment with inert product gutapercha.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regenerative Endodontic Procedure (REP)
Arm Type
Experimental
Arm Description
umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
Arm Title
Conventional Root Canal Treatment
Arm Type
Active Comparator
Arm Description
Conventional endodontic procedure
Intervention Type
Procedure
Intervention Name(s)
Regenerative Endodontic Procedure
Other Intervention Name(s)
REP, Tissue engineering procedure
Intervention Description
Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with stem cells.
Intervention Type
Procedure
Intervention Name(s)
Conventional Root Canal Treatment
Other Intervention Name(s)
Gold standard treatment
Intervention Description
Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with gutta-percha.
Primary Outcome Measure Information:
Title
Number of Participats Showing Efficacy (Functionality)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Pulpal Response
Description
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.
Time Frame
baseline, 6 months, 12 months
Title
Change in Apical Lesion Size
Description
Change in apical lesion size will be evaluated by cone beam tomography 6 and 12 months after intervention is completed.
Time Frame
baseline, 6 months, 12 months
Title
Pain to Percussion
Description
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.
Time Frame
baseline, 6 months, 12 months
Title
Numbers of Participants With Adverse Event
Description
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.
Time Frame
6 months, 12 months
Title
Pulp Regeneration
Description
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.
Time Frame
baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidad de los Andes
City
Santiago
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32202965
Citation
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.
Results Reference
derived

Learn more about this trial

Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration.

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