Clinical Trial: Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Encapsulated Mesenchymal Stem Cells for Endodontic Treatment of Permanent Teeth With Apical Lesion: a Controlled Clinical Trial.

Brief Summary: To compare the dental survival in a period of 2 years 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.

Detailed Summary: 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 2 years.
Sponsor: Universidad Los Andes, Chile

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Universidad Los Andes, Chile

Dates:
Date Received: March 21, 2017
Date Started: September 23, 2016
Date Completion: December 30, 2020
Last Updated: April 5, 2017
Last Verified: April 2017