- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03833401
Dental Pulp Regeneration by Autologous Tissue Transplantation
February 5, 2019 updated by: Mo K. Kang, DDS, PhD, University of California, Los Angeles
Dental Pulp Regeneration for Root Canals by Autologous Tissue Transplantation
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mo Kang, DDS,PhD
- Phone Number: 310-825-8048
- Email: mkang@dentistry.ucla.edu
Study Contact Backup
- Name: Yangpei Cao, DDS, MS
- Phone Number: 310-825-7165
- Email: ycao@dentistry.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- UCLA School of Dentistry
-
Contact:
- Lisa Gotori-Koga
- Phone Number: 310-825-7141
- Email: lgotori@dentistry.ucla.edu
-
Sub-Investigator:
- Yangpei Cao, DDS,MS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 48 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Root canal revascularization
Root canal disinfection and revascularization without tissue transplantation.
This will serve as control group.
|
Root canal disinfection and revascularization without tissue transplantation
|
Experimental: Autologous tissue transplantation
Root canal disinfection will be performed and revascularization will be induced with autologous tissue transplantation.
|
Root canal disinfection and revascularization with patient's own minced pulp tissues
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in radiographic assessment for periapical inflammation
Time Frame: 6 months, 12 months, and 24 months
|
This outcome will test the effect of treatment in either Arm on resolving periapical inflammation, which will be assessed by radiographic imaging and clinical examination.
Healing of periapical inflammatory lesion will be measured by radiographic imaging to note changes in the size of pre-existing radiograph periapical lesions after the treatment.
|
6 months, 12 months, and 24 months
|
Changes in pulpal sensibility to temperature and electric current
Time Frame: 6 months, 12 months, and 24 months
|
This outcome will test whether the treatment in either Arm will allow revitalization of pulp tissues, by means of thermal and electrical testing of pulp vitality.
|
6 months, 12 months, and 24 months
|
Changes in root dentin thickness of root canals
Time Frame: 6 months, 12 months, and 24 months
|
This outcome will assess changes in root dentin thickness after treatment in either arm.
We will also determine if the apical opening (foramen) will close in cases that initially present with open apices.
This assessment will be based on radiographic imaging.
|
6 months, 12 months, and 24 months
|
Changes in root length
Time Frame: 6 months, 12 months, and 24 months
|
This outcome will assess changes in root length after treatment in either arm.
This assessment will be based on radiographic imaging.
|
6 months, 12 months, and 24 months
|
Changes of root canal calcification in teeth treated by revascularization with or without tissue transplantation
Time Frame: 6 months, 12 months, and 24 months
|
This outcome will assess the degree of root canal calcification in teeth treated in either Arm by radiographic imaging.
Degree of calcification will be measured by means of different levels of radio-opacity in routine dental X rays.
|
6 months, 12 months, and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mo Kang, DDS,PhD, University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2019
Primary Completion (Anticipated)
June 30, 2021
Study Completion (Anticipated)
June 30, 2021
Study Registration Dates
First Submitted
February 5, 2019
First Submitted That Met QC Criteria
February 5, 2019
First Posted (Actual)
February 7, 2019
Study Record Updates
Last Update Posted (Actual)
February 7, 2019
Last Update Submitted That Met QC Criteria
February 5, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 18-000077
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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