Encapsulated Acellular System From Mesenchymal Stem Cells for Dental Pulp Regeneration

Phase 1

Recruiting

• Conditions: Periapical Periodontitis
• Interventions: Biological: Acellular system

• Registration Number: NCT05599087
• Lead Sponsor: Universidad de los Andes, Chile

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Last Update Submitted: 2022-10-25
• Study First Posted: 2022-10-31
• Last Update Posted: 2022-10-31
• Study Start: 2022-12-30
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acellular system	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.

Primary Outcome Measures

Name	Time	Method
Regeneration of dental pulp	6 months	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) .

Trial Locations

Locations (1)

Universidad de los Andes; 🇨🇱 Las Condes, Region Metropolitana, Chile