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
|Condition or disease||Intervention/treatment||Phase|
|Periapical Periodontitis||Procedure: Regenerative Endodontic Procedure Procedure: Conventional Root Canal Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Universidad de los Andes|