Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration. (RanoKure)
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|ClinicalTrials.gov Identifier: NCT03102879|
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Periapical Periodontitis||Procedure: Regenerative Endodontic Procedure Procedure: Conventional Root Canal Treatment||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Biological: umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial|
|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|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
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
- Tooth survival [ Time Frame: 24 months ]• Survival (period 2 years): The primary outcome measure for this study is to evaluate the survival of the tooth through the retention of the tooth in the mouth. This parameter will be evaluated 24 months after the intervention is completed.
- Change in pulpal response [ Time Frame: baseline, 1 week, 3 months, 6 months, 12 months, 24 months. ]• Change in pulpal response (period 2 years) will be assessed through sensitivity tests (cold, heat and electricity), and laser doppler flow cytometry. The pulp status will be evaluated 1 week after intervention is completed, then at 3, 6, 12, and 24 months.
- Change in apical lesion size [ Time Frame: baseline, 6 months, 12 months, 18 months, 24 months. ]• Change in apical lesion size will be evaluated by standardized periapical radiography at 6,12, 18 and 24 months after intervention is completed. It will also be evaluated by Cone Beam 12 months after the procedure.
- Change in symptoms [ Time Frame: baseline, 1 week, 3 months, 6 months, 12 months, 24 months. ]• Change in symptoms will be evaluated with percussion of the tooth. This will be monitored 1 week after the operation is completed, then at 3, 6, 12 and 24 months.
- Change in tooth color [ Time Frame: baseline, 12 months, 24 months. ]This will be evaluated comparing the color and translucency differences, between teeth with REP and the standard procedure. This will be normalized with the corresponding control teeth from each patient. This will be monitored 12 and 24 months after the operation is completed.
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
|Contact: Claudia Brizuelafirstname.lastname@example.org|
|Universidad de los Andes||Recruiting|
|Contact: Claudia Brizuela 56226181166 email@example.com|