Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-23

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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

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Periapical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Regenerative Endodontic Procedure (REP)

umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial.

Group Type EXPERIMENTAL

Regenerative Endodontic Procedure

Intervention Type PROCEDURE

Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with stem cells.

Conventional Root Canal Treatment

Conventional endodontic procedure

Group Type ACTIVE_COMPARATOR

Conventional Root Canal Treatment

Intervention Type PROCEDURE

Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with gutta-percha.

Interventions

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Regenerative Endodontic Procedure

Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with stem cells.

Intervention Type PROCEDURE

Conventional Root Canal Treatment

Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with gutta-percha.

Intervention Type PROCEDURE

Other Intervention Names

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REP Tissue engineering procedure Gold standard treatment

Eligibility Criteria

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Inclusion Criteria

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

* 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

* 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.

* 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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No