Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration. (RanoKure)

Universidad de los Andes, Chile

Status

Completed

Conditions

Periapical Periodontitis

Treatments

Procedure: Regenerative Endodontic Procedure

Procedure: Conventional Root Canal Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03102879

RPD-8-16

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

16 to 58 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient inclusion criteria:

Age: 16 - 58 years old.
Signed the informed consent.
Non-smoking.
Systemically healthy patients

Tooth inclusion criteria:

Upper and lower incisors, upper and lower canines and lower premolars teeth with mature apex and apical lesion (greater than 2 PAI and 1 CBCTPAI).
Teeth that do not response to both electrical and thermal pulp test
Teeth that can be restored (as defined by Class A or Class B using Samet and Jotkowitz classification) without the need of a stainless steel crown.

Exclusion criteria

Patient exclusion criteria:

Patients without a phone number for contact during the study.
Subjects not available for follow up period (12 months).
Patients who are or will undergo orthodontic treatment over the next 12 months.
Patients with an allergy to any material or drug used in the study.
Patients who are pregnant or lactating.
Patients with a history of systemic diseases that alter immune function, such as diabetes mellitus, immunodeficiency, leukemia, Addison's disease and Cushing.
Patients who have used immunosuppressive drugs or chemotherapy, 3 months before the study.

Tooth exclusion criteria:

Endodontically treated teeth
Teeth with signs of severe root resorption.
Teeth with mobility class III or Dens invaginatus.
Teeth with avulsion history and conservation in a dry extraoral medium for more than 1 hour.
Teeth with clinical and / or radiographic evidence of root fracture.
Teeth that can not be absolutely isolated with rubber dam. . Teeth with more than one root or root canal.