NCT01814436

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

Status unknown NA Last updated 26 April 2016

What this trial tests

NA trial testing scaffold-free SHED-derived pellet in Dental Pulp Necrosis in 80 participants. Status unknown.

Timeline

1 February 2013

Primary endpoint
1 July 2017

1 October 2017

Quick facts

Lead sponsor	Air Force Military Medical University, China
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	1 February 2013
Primary completion	1 July 2017
Estimated completion	1 October 2017
Sites	1 location across China

Drugs / interventions tested

• scaffold-free SHED-derived pellet

Conditions studied

• Dental Pulp Necrosis — all drugs for Dental Pulp Necrosis →
• Permanent Incisor Avulsed by Trauma — all drugs for Permanent Incisor Avulsed by Trauma →

Sponsor

Air Force Military Medical University, China

Who can join

Adults 7 to 12, any sex, with Dental Pulp Necrosis or Permanent Incisor Avulsed by Trauma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stem cell-based bone and dental regeneration: a view of microenvironmental modulation.
   Zheng C, Chen J, Liu S, Jin Y. · · 2019 · cited 162× · PMID 31423011 · DOI 10.1038/s41368-019-0060-3
2. Immunomodulatory properties of mesenchymal stem cells/dental stem cells and their therapeutic applications.
   Li P, Ou Q, Shi S, Shao C. · · 2023 · cited 157× · PMID 36973490 · DOI 10.1038/s41423-023-00998-y
3. Stem Cells of Dental Origin: Current Research Trends and Key Milestones towards Clinical Application.
   Bakopoulou A, About I. · · 2016 · cited 54× · PMID 27818690 · DOI 10.1155/2016/4209891
4. Promising advances in clinical trials of dental tissue-derived cell-based regenerative medicine.
   Yamada Y, Nakamura-Yamada S, Konoki R, Baba S. · · 2020 · cited 48× · PMID 32398041 · DOI 10.1186/s13287-020-01683-x
5. Application of Stem Cells in Oral Disease Therapy: Progresses and Perspectives.
   Yang B, Qiu Y, Zhou N, Ouyang H, et al · · 2017 · cited 32× · PMID 28421002 · DOI 10.3389/fphys.2017.00197
6. The Neurovascular Properties of Dental Stem Cells and Their Importance in Dental Tissue Engineering.
   Ratajczak J, Bronckaers A, Dillen Y, Gervois P, et al · · 2016 · cited 32× · PMID 27688777 · DOI 10.1155/2016/9762871
7. Clinical trials using dental stem cells: 2022 update.
   Song WP, Jin LY, Zhu MD, Wang H, et al · · 2023 · cited 25× · PMID 37007456 · DOI 10.4252/wjsc.v15.i3.31
8. Mechanisms underlying dental-derived stem cell-mediated neurorestoration in neurodegenerative disorders.
   Raza SS, Wagner AP, Hussain YS, Khan MA. · · 2018 · cited 22× · PMID 30257724 · DOI 10.1186/s13287-018-1005-z