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Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration

NCT ID: NCT05599087

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-30

Study Completion Date

2023-12-30

Brief Summary

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To evaluate the security and efficacy in the administration of encapsulated acellular system derived from Mesenchymal Stem Cells as a novel regenerative endodontic procedure which to promote the pulpar regenration.

Detailed Description

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Conditions

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Periapical Periodontitis

Keywords

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mesenchymal stem cells regenerative procedures dental pulp pulp regeneration allogenic acellular system

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acellular system

Regenerative Endodontic Procedure (REP) the acellular system derived from umbilical cord-derived mesenchymal stem cells encapsulated in a platelet-poor plasma-derived biomaterial.

Group Type EXPERIMENTAL

Acellular system

Intervention Type BIOLOGICAL

Regenerative Endodontic Procedure Tissue engineering procedure

Interventions

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Acellular system

Regenerative Endodontic Procedure Tissue engineering procedure

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Systemically healthy patients (ASA I).
* Patient presenting with a maxillary or mandibular incisor/canine and mandibular premolar with mature apex, pulpal necrosis, and apical radiographic evidence of apical periodontitis (PAI ≥2 and CBCTPAI ≥1).
* Patient presents with a tooth that does not respond to electrical and thermal pulp testing.
* Patients with restorable teeth (considering the definition of class A or B, according to Samet and Jotkowitz classification) without the need for a single fine prosthesis (crown) or major restoration.

Exclusion Criteria

* Patients not available for the follow-up period (27 weeks).
* Patients who will undergo orthodontic treatment in the next six months.
* Patients with reports of allergies to any material or medication used in the study.
* Pregnant patients.
* Heavy smokers (more than 10 cigarettes per day).
* Patients with a history of systemic diseases that impair immune function, such as diabetes mellitus, immunodeficiency, leukemia, Addison's and Cushing's disease.
* Patients who have used immunosuppressive drugs or chemotherapy, 3 months before the study. Or that they will be irradiated or undergo chemotherapy.
* Patients who have endodontically treated teeth.
* Patients who have teeth with signs of severe root resorption.
* Patients who have teeth with mobility class III or Dens invaginatus.
* Patients who have teeth with a history of avulsion-type dentoalveolar trauma.
* Patients who have teeth with clinical and/or radiographic evidence of root fracture.
* Patients who have teeth that cannot be completely isolated with rubber dam.
* Patients who have teeth with more than one root or root canal.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cells for Cells

INDUSTRY

Sponsor Role collaborator

Universidad de los Andes, Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universidad de los Andes

Las Condes, Santiago Metropolitan, Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Claudia Brizuela

Role: CONTACT

Phone: 95349948

Email: [email protected]

Facility Contacts

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Claudia Brizuela

Role: primary

Other Identifiers

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UAndes2

Identifier Type: -

Identifier Source: org_study_id