Revitalization of Immature Permanent Teeth With Necrotic Pulps Using SHED Cells
Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem Cells from Human Exfoliated Deciduous Teeth
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem Cells From Human Exfoliated Deciduous Teeth|
- Pulp and Apical regeneration [ Time Frame: 1 year following transplantation ] [ Designated as safety issue: Yes ]
The main outcome measures in the study protocol were: pulp status evaluated by dental pulp vitality tester; pulp revascularization examined by laser dopler flow meter, and the index of clinical examination. In addition, we examined whether and to what extent adverse events, for which causal relationships with the use of SHED cell was not ruled out, emerged.
The other main outcome measures in the study protocol were: the degree of apical closure; the rate of increase in root length and the change of root canal wall thickness. We examined and evaluate the anatomic morphology of teeth roots using dental computer tomography. We set rate of increase in root length as the most statistically important outcome (primary outcome).
- Clinical parameters [ Time Frame: 3~12 month following transplantation ] [ Designated as safety issue: No ]periapical lesion and tooth mobility
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|Experimental: scaffold-free SHED-derived pellet||
Device: scaffold-free SHED-derived pellet
The purpose of this clinical trial is to both clarify the efficiency of autologous SHED to regenerate pulp and apical tissue in the patients with immature permanent teeth and pulp necrosis to confirm the safety of using autologous stem cells in clinical endodontic regenerative medicine.
Other Name: SHED pellet
Irreversible damage to immature permanent teeth as a result of noxious infection or local trauma before normal physiological closure of the apical structure represents a real clinical challenge. The conventional therapeutic approach is to consider the use of synthetic biocompatible materials, such as calcium hydroxide [Ca(OH)2] and mineral trioxide aggregate (MTA), to induce apical closure, or apexification, by forming a hard tissue barrier across the root apex. However, neither MTA nor calcium hydroxide are currently able either to induce or stimulate pulp regeneration, or to ensure that conventional root development continues once damage has taken place, so that the inherent risk of root fracture remains. Along with the development of new regenerative protocols to resolve clinical deficiencies, continuing advances in the discovery and characterization of stem cells of dental origin—able to differentiate into multiple tissue types—have recently broadened possible therapeutic horizons towards pulp tissue regeneration and apexogenesis. Some studies have suggested that the recent discovery and characterization of stem cells from human exfoliated deciduous teeth (SHED) form the cell source of apexogenesis in immature teeth with periradicular periodontitis of endodontic origin. The purpose of this clinical trial is to both clarify the efficiency of autologous SHED to regenerate pulp and apical tissue in the patients with immature permanent teeth and pulp necrosis to confirm the safety of using autologous stem cells in clinical endodontic regenerative medicine. This is a single-centre, randomized, placebo-controlled study. This study has been approved by the ethical committees of School of Stomatology, Fourth Military Medical University. The study will be conducted according to the Declaration of Helsinki.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01814436
|Contact: kun firstname.lastname@example.org|
|Contact: yan email@example.com|
|School of Stomatology, Fourth Military Medical University||Recruiting|
|Xi'an, Shaanxi, China, 710032|
|Contact: Yan Jin, PhD 86-29-84776147 firstname.lastname@example.org|
|Principal Investigator: yan Jin, PhD|
|Principal Investigator: Kun Xuan, PhD|
|Sub-Investigator: yongjie zhang, PhD|
|Principal Investigator:||songtao shi, PhD||chool of Stomatology, Fourth Military Medical Univeristy; Ostrow School of Dentistry, University of Southern California|