Revitalization of Immature Permanent Teeth With Necrotic Pulps Using SHED Cells

NCT01814436 | Unknown DMC

• 1 other identifier: FourthMMU2013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem Cells from Human Exfoliated Deciduous Teeth

Conditions

Dental Pulp Necrosis; Permanent Incisor Avulsed by Trauma

Outcome Measures

Primary Outcomes (1)

• Pulp and Apical regeneration

  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).

  1 year following transplantation

Secondary Outcomes (1)

• Clinical parameters

  3~12 month following transplantation

Study Arms (1)

scaffold-free SHED-derived pellet

EXPERIMENTAL

Device: scaffold-free SHED-derived pellet

Interventions

scaffold-free SHED-derived pellet DEVICE

The purpose of this clinical trial is to both clarify the efficiency of autologous SHED to regenerate pulp and periodontal tissue in the patients with avulsed immature permanent teeth and pulp necrosis to confirm the safety of using autologous stem cells in clinical endodontic regenerative medicine.

Also known as: SHED pellet

scaffold-free SHED-derived pellet

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Those who has signed the informed consent.
• Those who are between 7-years-old to 12-years-old.
• Those with at least one young permanent teeth with pulp necrosis which caused by trauma or permanent incisor avulsed by trauma.
• Those who can provide the health deciduous teeth.
• Those who have accomplished initial preparation and have been showing good compliance.
• Those whose guardians understand the purposes of the trial and are capable of making an independent decision to comply with trial requirements
• Those who are able to visit our hospital in accordance with the trial schedule

You may not qualify if:

• Those in an extremely poor nutritional condition (serum albumin concentration \<2 g/dL)
• Those whose guardians would not cooperate with the treatment.
• Those who has uncontrollable oral disease.
• Those with severe dental fear.
• Those with coexisting mental or consciousness disorder.
• Those with teeth dysplasia and/or hereditary disease history.
• Those with systemic disease which may affect the postoperative healing.
• Those with bruxism and malocclusion.
• Loss of the avulsed teeth.
• Those who are taking the medicine which would affect the postoperative healing.
• Those with the bad oral habits.
• Those who are undertaking other trail meanwhile or few weeks ago.
• Those coexisting disease of the blood or immune system.
• Those who are not capable to provide the deciduous dental pulp cells.
• Those with the severe tooth trauma (crown-root or root fracture, tooth displacement).

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

School of Stomatology, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• songtao shi, PhD

  chool of Stomatology, Fourth Military Medical Univeristy; Ostrow School of Dentistry, University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

kun xuan

CONTACT

86-29-84776087; xuankun@fmmu.edu.cn

yan jin

CONTACT

86-29-84776147; yanjin@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2013
• First Posted: March 20, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

CN (1)