Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration

Periapical Periodontitis Clinical Trial

Official title:

Encapsulated Acellular System From Mesenchymal Stem Cells for Endodontic Treatment of Patients With Apical Periodontitis: Phase I Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599087
• Other study ID #: UAndes2
• Status: Recruiting
• Phase: Phase 1
• Start date: December 30, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2022
• Source: Universidad de los Andes, Chile
• Contact: Claudia Brizuela
• Phone: 95349948
• Email: clau[@]cibrizuela.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis

Intervention

Biological:
• Acellular system
Regenerative Endodontic Procedure Tissue engineering procedure

Locations

Country	Name	City	State
Chile	Universidad de los Andes	Las Condes	Region Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de los Andes, Chile	Cells for Cells, Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) .	6 months