NCT03102879

Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Universidad de los Andes, Chile · Academic / Other
• Sex: All
• Age: 16 Years – 58 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Periapical Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Regenerative Endodontic Procedure	Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with stem cells.
PROCEDURE	Conventional Root Canal Treatment	Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with gutta-percha.

Timeline

• Start date: 2016-09-23
• Primary completion: 2018-09-30
• Completion: 2018-09-30
• First posted: 2017-04-06
• Last updated: 2020-01-21
• Results posted: 2020-01-21

Locations

1 site across 1 country: Chile