Clinical Trial: Revitalization of Immature Permanent Teeth With Necrotic Pulps Using SHED Cells
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem Cells From Human Exfoliated Deciduous Teeth
Brief Summary: Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem Cells from Human Exfoliated Deciduous Teeth
Detailed Summary:
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.
Millions of teeth are accidentally avulsed each year due to the serious trauma in sports, motor vehicle accidents, criminal assaults, and fist fights, among other incidents. The risk is higher in children while their permanent teeth are still immature which may led to lots of complications and also more challenges in treatment. Generally, tooth reimplantation is the most effective therapy for tooth avulsion, As we know, The success of tooth reimplantation depends on the maintenance of vitality of the periodontal ligament, which need the parents and teachers act quickly (e.g., within 2 h) and that the avulsed tooth should preserved in an appropriate medium, such as milk or physiological saline, because the viable cells in the remaining periodontal ligament (PDL) on the root surface play a crucial role in recovering the avulsed tooth functions.
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 therapeu
Sponsor: Fourth Military Medical University
Current Primary Outcome: Pulp and Apical regeneration [ Time Frame: 1 year following transplantation ]
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).
Original Primary Outcome: Same as current
Current Secondary Outcome: Clinical parameters [ Time Frame: 3~12 month following transplantation ]
Original Secondary Outcome: Same as current
Information By: Fourth Military Medical University
Dates:
Date Received: March 16, 2013
Date Started: February 2013
Date Completion: October 2017
Last Updated: April 26, 2016
Last Verified: April 2016
