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| Name | Class |
|---|---|
| Cells for Cells | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regenerative Endodontic Procedure (REP) | Experimental | umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. |
|
| Conventional Root Canal Treatment | Active Comparator | Conventional endodontic procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regenerative Endodontic Procedure | Procedure | Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with stem cells. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 6 months, 12 months |
| Change in Apical Lesion Size |
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Inclusion Criteria:
Patient inclusion criteria:
Tooth inclusion criteria:
Exclusion Criteria:
Patient exclusion criteria:
Tooth exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de los Andes | Santiago | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32202965 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Regenerative Procedure | Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. |
| FG001 | Endodontic Treatment | Conventional root canal treatment treatment with inert product gutapercha. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Regenerative Procedure | Endodontic regenerative treatment with biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. |
| BG001 | Endodontic Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 months |
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regenerative Procedure | Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claudia Brizuela | Universidad de los Andes | 56 2 26181166 | clau@cibrizuela.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2019 | Dec 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
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2 interventions:
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|
| Conventional Root Canal Treatment | Procedure | Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with gutta-percha. |
|
|
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 | 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 | 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 | 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 |
Conventional root canal treatment treatment with inert product gutapercha.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | baseline, 6 months, 12 months |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | milimeters | baseline, 6 months, 12 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | baseline, 6 months, 12 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 6 months, 12 months |
|
|
|
| Secondary | 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. | 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. | Posted | Median | Inter-Quartile Range | % PU in time in relation to controltooth | baseline, 6 months, 12 months |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Conventional Treatment | Conventional Endodontic treatment | 0 | 18 | 0 | 18 | 0 | 18 |
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| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |
| Basal Hot Test |
|
| Basal Electrical Test |
|
| 6 months Cold Test |
|
| 6 months Hot Test |
|
| 6 months Electrical Test |
|
| 12 months Cold Test |
|
| 12 months Hot Test |
|
| 12 months Electrical Test |
|
| Basal Antero-Posterior |
|
| 6 months Mesio-Distal |
|
| 6 months Height |
|
| 6 months Antero-Posterior |
|
| 12 months Mesio-Distal |
|
| 12 months Height |
|
| 12 months Anterio-Posterior |
|
| 6 months Pain to Percussion |
|
| 12 months Pain to Percussion |
|
| Title | Measurements |
|---|---|
|