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Trial record 1 of 1 for:    NCT03102879
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Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration. (RanoKure)

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ClinicalTrials.gov Identifier: NCT03102879
Recruitment Status : Completed
First Posted : April 6, 2017
Results First Posted : January 21, 2020
Last Update Posted : January 21, 2020
Sponsor:
Collaborator:
Cells for Cells, Chile
Information provided by (Responsible Party):
Dra. Claudia Brizuel, Universidad de los Andes, Chile

Study Description
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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.

Condition or disease Intervention/treatment Phase
Periapical Periodontitis Procedure: Regenerative Endodontic Procedure Procedure: Conventional Root Canal Treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Encapsulated Mesenchymal Stem Cells for Endodontic Treatment of Permanent Teeth With Apical Lesion: a Controlled Clinical Trial.
Actual Study Start Date : September 23, 2016
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018
Arms and Interventions
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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 Name: Gold standard treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


  4. 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.

  5. 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.



Eligibility Criteria
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Ages Eligible for Study:   16 Years to 58 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102879


Locations
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Chile
Universidad de los Andes
Santiago, Chile
Sponsors and Collaborators
Universidad de los Andes, Chile
Cells for Cells, Chile
  Study Documents (Full-Text)

Documents provided by Dra. Claudia Brizuel, Universidad de los Andes, Chile:
Study Protocol and Statistical Analysis Plan  [PDF] January 5, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dra. Claudia Brizuel, Doctor of Dental Surgery, Universidad de los Andes, Chile
ClinicalTrials.gov Identifier: NCT03102879    
Other Study ID Numbers: RPD-8-16
First Posted: April 6, 2017    Key Record Dates
Results First Posted: January 21, 2020
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Dra. Claudia Brizuel, Universidad de los Andes, Chile:
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
Additional relevant MeSH terms:
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Periodontitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
 Stomatognathic Diseases
Periapical Diseases
Jaw Diseases