Clinical trial NCT03102879: Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration.
Official title: Encapsulated Mesenchymal Stem Cells for Endodontic Treatment of Permanent Teeth With Apical Lesion: a Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periapical Periodontitis
Keywords: mesenchymal stem cells
regenerative procedures
tissue engineering
regenerative endodontic
scaffold
cell encapsulation
dental pulp
pulp regeneration
plasma-derived biomaterial
allogenic stem cells
mesenchymal stromal cells
adult stem cells
umbilical cord stem cells
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
Collaborators: name: Cells for Cells
First posted: 2017-04-06
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Maximum age (years): 58
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 interventions:

1. Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.
2. Endodontic treatment with inert product gutapercha.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participats Showing Efficacy (Functionality)
timeFrame: 12 months
Secondary outcomes:
measure: Change in Pulpal Response
timeFrame: baseline, 6 months, 12 months
measure: Change in Apical Lesion Size
timeFrame: baseline, 6 months, 12 months
measure: Pain to Percussion
timeFrame: baseline, 6 months, 12 months
measure: Numbers of Participants With Adverse Event
timeFrame: 6 months, 12 months
measure: Pulp Regeneration
timeFrame: baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad de los Andes
Study officials:
References:
citation: Brizuela C, Meza G, Urrejola D, Quezada MA, Concha G, Ramirez V, Angelopoulos I, Cadiz MI, Tapia-Limonchi R, Khoury M. Cell-Based Regenerative Endodontics for Treatment of Periapical Lesions: A Randomized, Controlled Phase I/II Clinical Trial. J Dent Res. 2020 May;99(5):523-529. doi: 10.1177/0022034520913242. Epub 2020 Mar 23.