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Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration

Primary Purpose

Periapical Periodontitis

Status
Recruiting
Phase
Phase 1
Locations
Chile
Study Type
Interventional
Intervention
Acellular system
Sponsored by
Universidad de los Andes, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Periodontitis focused on measuring mesenchymal stem cells, regenerative procedures, dental pulp, pulp regeneration, allogenic acellular system

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad de los AndesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acellular system

Arm Description

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

Outcomes

Primary Outcome Measures

Regeneration of dental pulp
Patients are expected to have a decrease in the size of the periapical lesion in some of the three dimensions, or an increase of no more than 0.1 mm in one of them, when evaluating radiographic and cone beam computed tomography (CBCT) .

Secondary Outcome Measures

Full Information

First Posted
October 25, 2022
Last Updated
October 25, 2022
Sponsor
Universidad de los Andes, Chile
Collaborators
Cells for Cells, Chile
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1. Study Identification

Unique Protocol Identification Number
NCT05599087
Brief Title
Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration
Official Title
Encapsulated Acellular System From Mesenchymal Stem Cells for Endodontic Treatment of Patients With Apical Periodontitis: Phase I Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2022 (Anticipated)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de los Andes, Chile
Collaborators
Cells for Cells, Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periapical Periodontitis
Keywords
mesenchymal stem cells, regenerative procedures, dental pulp, pulp regeneration, allogenic acellular system

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acellular system
Arm Type
Experimental
Arm Description
Regenerative Endodontic Procedure (REP) the acellular system derived from umbilical cord-derived mesenchymal stem cells encapsulated in a platelet-poor plasma-derived biomaterial.
Intervention Type
Biological
Intervention Name(s)
Acellular system
Intervention Description
Regenerative Endodontic Procedure Tissue engineering procedure
Primary Outcome Measure Information:
Title
Regeneration of dental pulp
Description
Patients are expected to have a decrease in the size of the periapical lesion in some of the three dimensions, or an increase of no more than 0.1 mm in one of them, when evaluating radiographic and cone beam computed tomography (CBCT) .
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Brizuela
Phone
95349948
Email
clau@cibrizuela.com
Facility Information:
Facility Name
Universidad de los Andes
City
Las Condes
State/Province
Region Metropolitana
ZIP/Postal Code
7620157
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Brizuela
Phone
56226181166
Email
clau@cibrizuela.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration

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