Dental Pulp Regeneration by Autologous Tissue Transplantation

NCT ID: NCT03833401

Last Updated: 2019-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2021-06-30

Brief Summary

The purpose of this study is to develop new improved therapy for teeth that require root canals due to tooth infection or tooth inflammation. Investigators will recruit total of 50 participants from the age group 7 - 50 at the UCLA School of Dentistry Endodontic clinic. The participants will be divided into two groups, one will receive traditional therapy, which may include root canal or a procedure called "revascularization," which is a procedure trying to regrow the tissue inside the tooth. The other group of participants will receive the test treatment, which will involve harvesting of pulp tissues from the same tooth or other teeth that are planned for extraction. Investigators will prepare these tissues and place the tissues back into the cleaned root canal space with induced bleeding to allow regrowth of the tissue. For all participants, investigators will follow up after 6, 12, and 24 months in a shorter appointment, which may involve taking x-ray and clinical exam.

Detailed Description

The goal of the study is to test whether autologous pulpal mesenchymal stem cells (MSCs) is capable of de novo regeneration of pulp-dentin complex and restoration of normal pulp physiology in teeth with necrotic or inflamed pulp. This is a highly novel study that will bring the regenerative endodontic approaches to the next level. Furthermore, revascularization approaches, as delivered in today's endodontic offices, present several challenges, including lack of de novo pulp-dentin regeneration, and frequent occurrence of intracanal calcification. These findings attest to the limitation of revascularization as a regenerative endodontic procedure (REP) and necessitates advent of novel approach for functional restoration of dental pulp. The ultimate objective of the current study is to develop a new REP that allows for de novo regeneration of functional dental pulp, which can be readily performed in a chair-side manner.

Conditions

Dental Pulp Regeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Root canal revascularization

Root canal disinfection and revascularization without tissue transplantation. This will serve as control group.

Group Type: SHAM_COMPARATOR

Root canal revascularization

Intervention Type: PROCEDURE

Root canal disinfection and revascularization without tissue transplantation

Autologous tissue transplantation

Root canal disinfection will be performed and revascularization will be induced with autologous tissue transplantation.

Group Type: EXPERIMENTAL

Autologous tissue transplantation

Intervention Type: PROCEDURE

Root canal disinfection and revascularization with patient's own minced pulp tissues

Interventions

Root canal revascularization

Root canal disinfection and revascularization without tissue transplantation

Intervention Type: PROCEDURE

Autologous tissue transplantation

Root canal disinfection and revascularization with patient's own minced pulp tissues

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Healthy male or female participants at ages of 7 - 50 y.o. presenting with a tooth diagnosed with complete or partial necrosis of the pulp or irreversible pulpitis.
• Participants presenting with donor pulp tissue, either from existing deciduous teeth or from permanent teeth treatment planned for extraction, e.g., second premolars for orthodontic extraction or third molars.
• Participants presenting with irreversible pulpitis and partial necrosis, i.e., visible pulpal tissues during access opening and canal debridement.
• Participants with immature root apices, including those with partially closed apex, that require root canal procedure.

Exclusion Criteria

• Participants with any systemic conditions preventing routine dental procedures or requiring medication that interfere with healing or induce bleeding.
• Participants with avulsed, replanted teeth with resultant pulp necrosis.
• Participants with vertical root fracture/cracks.
• Participants with teeth that are not restorable.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Mo K. Kang, DDS, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mo Kang, DDS,PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA School of Dentistry

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mo Kang, DDS,PhD

Role: CONTACT

mkang@dentistry.ucla.edu

310-825-8048

Yangpei Cao, DDS, MS

Role: CONTACT

ycao@dentistry.ucla.edu

310-825-7165

Facility Contacts

Lisa Gotori-Koga

Role: primary

lgotori@dentistry.ucla.edu

310-825-7141

Other Identifiers

18-000077

Identifier Type: -

Identifier Source: org_study_id