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Cell-Based Regenerative Endodontics for Treatment of Periapical Lesions: A Randomized, Controlled Phase I/II Clinical Trial.

Authors
  • Brizuela, C1
  • Meza, G1
  • Urrejola, D1
  • Quezada, M A1
  • Concha, G1
  • Ramírez, V1
  • Angelopoulos, I2
  • Cadiz, M I2, 3
  • Tapia-Limonchi, R2, 3
  • Khoury, M2, 3, 4
  • 1 Centro "Activa Biosilicate Technology™" de Investigación en Biología y Regeneración Oral (CIBRO), Faculty of Dentistry, Universidad de los Andes, Santiago, Chile. , (Chile)
  • 2 Laboratory of Nano-Regenerative Medicine, Faculty of Medicine, Universidad de los Andes, Santiago, Chile. , (Chile)
  • 3 Consorcio Regenero, Chilean Consortium for Regenerative Medicine, Santiago, Chile. , (Chile)
  • 4 Cells for Cells, Santiago, Chile. , (Chile)
Type
Published Article
Journal
Journal of dental research
Publication Date
May 01, 2020
Volume
99
Issue
5
Pages
523–529
Identifiers
DOI: 10.1177/0022034520913242
PMID: 32202965
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

A randomized controlled phase I/II clinical trial was designed to evaluate the safety and efficacy of encapsulated human umbilical cord mesenchymal stem cells in a plasma-derived biomaterial for regenerative endodontic procedures (REPs) in mature permanent teeth with apical lesions. The trial included 36 patients with mature incisors, canines, or mandibular premolars showing pulp necrosis and apical periodontitis. Patients were randomly and equally allocated between experimental (REP) or conventional root canal treatment (ENDO) groups. On the first visit, cavity access and mechanical preparation of the root canal were performed. Calcium hydroxide medication was used, and the cavity was sealed. Three weeks later, patients were treated following their assigned protocol of ENDO or REP. Clinical follow-up examinations were performed at 6 and 12 mo. Categorical variables were evaluated by Fisher's exact test. Quantitative variables were compared using the Mann-Whitney test. The evolution over time of the percentage of perfusion units and the dimensions of lesion and cortical compromise were explored. After the 12-mo follow-up, no adverse events were reported, and the patients showed 100% clinical efficacy in both groups. Interestingly, in the REP group, the perfusion unit percentage measured by laser Doppler flowmetry revealed an increase from 60.6% to 78.1% between baseline and 12-mo follow-up. Sensitivity tests revealed an increase of the positive pulp response in the REP group at 12-mo follow-up (from 6% to 56% on the cold test, from 0% to 28% on the hot test, and from 17% to 50% on the electrical test). We present the first clinical safety and efficacy evidence of the endodontic use of allogenic umbilical cord mesenchymal stem cells encapsulated in a plasma-derived biomaterial. The innovative approach, based on biological principles that promote dentin-pulp regeneration, presents a promising alternative for the treatment of periapical pathology (ClinicalTrials.gov NCT03102879).

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