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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Periapical Periodontitis
Interventions Procedure: Regenerative Endodontic Procedure
Procedure: Conventional Root Canal Treatment
Enrollment 36
Recruitment Details Recruitment between September 2016 and September 2017, from patients referred for endodontic treatment to the Universidad de los Andes Health Center, located in San Bernardo city, Santiago, Chile.
Pre-assignment Details  
Arm/Group Title Regenerative Procedure Endodontic Treatment
Hide Arm/Group Description Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. Conventional root canal treatment treatment with inert product gutapercha.
Period Title: Overall Study
Started 18 18
Completed 18 18
Not Completed 0 0
Arm/Group Title Regenerative Procedure Endodontic Treatment Total
Hide Arm/Group Description Endodontic regenerative treatment with biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. Conventional root canal treatment treatment with inert product gutapercha. Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 18 participants 18 participants 36 participants
27
(22 to 39)
28
(24 to 43)
27
(23 to 40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female 12 13 25
Male 6 5 11
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Participats Showing Efficacy (Functionality)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regenerative Procedure Endodontic Treatment
Hide Arm/Group Description:
Endodontic regenerative treatment with biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
Conventional root canal treatment treatment with inert product gutapercha.
Overall Number of Participants Analyzed 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
18
 100.0%
18
 100.0%
2.Secondary Outcome
Title Change in Pulpal Response
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regenerative Procedure Conventional Treatment
Hide Arm/Group Description:
Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
Conventional Endodontic treatment
Overall Number of Participants Analyzed 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
Basal Cold Test Response
1
   5.6%
1
   5.6%
No Response
17
  94.4%
17
  94.4%
Basal Hot Test Response
0
   0.0%
1
   5.6%
No Response
18
 100.0%
17
  94.4%
Basal Electrical Test Response
3
  16.7%
1
   5.6%
No Response
15
  83.3%
17
  94.4%
6 months Cold Test Response
14
  77.8%
2
  11.1%
No Response
4
  22.2%
16
  88.9%
6 months Hot Test Response
2
  11.1%
0
   0.0%
No Response
16
  88.9%
18
 100.0%
6 months Electrical Test Response
4
  22.2%
4
  22.2%
No Response
14
  77.8%
14
  77.8%
12 months Cold Test Response
10
  55.6%
1
   5.6%
No Response
8
  44.4%
17
  94.4%
12 months Hot Test Response
5
  27.8%
0
   0.0%
No Response
13
  72.2%
18
 100.0%
12 months Electrical Test Response
9
  50.0%
3
  16.7%
No Response
9
  50.0%
15
  83.3%
3.Secondary Outcome
Title Change in Apical Lesion Size
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regenerative Endodontic Procedure (REP) Conventional Root Canal Treatment
Hide Arm/Group Description:
umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
Conventional endodontic procedure
Overall Number of Participants Analyzed 18 18
Median (Inter-Quartile Range)
Unit of Measure: milimeters
Basal Mesio-Distal
5
(4.2 to 7.7)
5.5
(3.3 to 6.7)
Basal Height
5.5
(4.7 to 8.9)
7.1
(2.9 to 10.1)
Basal Antero-Posterior
5
(4.6 to 6)
5.1
(3.3 to 6.2)
6 months Mesio-Distal
2.7
(2 to 5.1)
2.4
(0.9 to 5.9)
6 months Height
2.6
(2.4 to 4.6)
2.5
(1.4 to 4.3)
6 months Antero-Posterior
2.4
(2.2 to 4.4)
3
(1.7 to 4)
12 months Mesio-Distal
2
(1.4 to 3.4)
1.7
(0.9 to 3.4)
12 months Height
1.8
(0.8 to 4.1)
1.5
(0.4 to 4.4)
12 months Anterio-Posterior
2.1
(1.1 to 4.1)
1.7
(0.6 to 3.3)
4.Secondary Outcome
Title Pain to Percussion
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regenerative Procedure Conventional Treatment
Hide Arm/Group Description:
Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
Conventional Endodontic treatment
Overall Number of Participants Analyzed 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Pain to Percussion Positive
11
  61.1%
5
  27.8%
Negative
7
  38.9%
13
  72.2%
6 months Pain to Percussion Positive
1
   5.6%
0
   0.0%
Negative
17
  94.4%
18
 100.0%
12 months Pain to Percussion Positive
0
   0.0%
0
   0.0%
Negative
18
 100.0%
18
 100.0%
5.Secondary Outcome
Title Numbers of Participants With Adverse Event
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Regenerative Procedure Conventional Treatment
Hide Arm/Group Description:
Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
Conventional Endodontic treatment
Overall Number of Participants Analyzed 18 18
Measure Type: Count of Participants
Unit of Measure: Participants
6 months
0
   0.0%
0
   0.0%
12 months
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Pulp Regeneration
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was not measured in conventional treatment group due to the nature of the filling material, which does not promote revitalization of the pulp.
Arm/Group Title Regenerative Procedure
Hide Arm/Group Description:
Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
Overall Number of Participants Analyzed 18
Median (Inter-Quartile Range)
Unit of Measure: % PU in time in relation to controltooth
Basal
60.6
(53.5 to 75)
6 months
74.4
(49.2 to 102.2)
12 months
78.1
(54.7 to 99.3)
Time Frame Adverse events were collected 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.
Adverse Event Reporting Description Safety encompassed immediate adverse events after implantation of UC-MSCs in the REP group or gutta-percha in the ENDO group, as defined by root fracture, severe or moderate pain and extra-intraoral inflammation.
 
Arm/Group Title Regenerative Procedure Conventional Treatment
Hide Arm/Group Description Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. Conventional Endodontic treatment
All-Cause Mortality
Regenerative Procedure Conventional Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Hide Serious Adverse Events
Regenerative Procedure Conventional Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Regenerative Procedure Conventional Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Claudia Brizuela
Organization: Universidad de los Andes
Phone: 56 2 26181166
EMail: clau@cibrizuela.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dra. Claudia Brizuel, Universidad de los Andes, Chile
ClinicalTrials.gov Identifier: NCT03102879    
Other Study ID Numbers: RPD-8-16
First Submitted: March 21, 2017
First Posted: April 6, 2017
Results First Submitted: December 10, 2019
Results First Posted: January 21, 2020
Last Update Posted: January 21, 2020