Dental Pulp RegenerationNCT03833401
Dental Pulp Regeneration by Autologous Tissue Transplantation
A study testing Autologous tissue transplantation and Root canal revascularization in people with Dental Pulp Regeneration, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Regeneration
- What is being tested?
- Autologous tissue transplantation and Root canal revascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA School of Dentistry
Los Angeles, California, 90095
About this study
Official title: 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.
Read the 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
- Being tested
- Autologous tissue transplantation, Root canal revascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous tissue transplantationProcedure or surgery
Root canal disinfection and revascularization with patient's own minced pulp tissues
Root canal revascularizationProcedure or surgery
Root canal disinfection and revascularization without tissue transplantation
| Study group | Role | What they receive |
|---|---|---|
| Root canal revascularization | Sham comparator | Root canal disinfection and revascularization without tissue transplantation. This will serve as control group. Receives: Procedure: Root canal revascularization |
| Autologous tissue transplantation | Experimental | Root canal disinfection will be performed and revascularization will be induced with autologous tissue transplantation. Receives: Procedure: Autologous tissue transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in radiographic assessment for periapical inflammation
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.
Measured: 6 months, 12 months, and 24 months
Changes in pulpal sensibility to temperature and electric current
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.
Measured: 6 months, 12 months, and 24 months
Changes in root dentin thickness of root canals
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.
Measured: 6 months, 12 months, and 24 months
Changes in root length
This outcome will assess changes in root length after treatment in either arm. This assessment will be based on radiographic imaging.
Measured: 6 months, 12 months, and 24 months
Changes of root canal calcification in teeth treated by revascularization with or without tissue transplantation
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.
Measured: 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start14 Feb 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp RegenerationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will involve two Arms; one serving as sham comparator, and the other arm serving as experimental (test) group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mo Kang, DDS,PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833401
- Sponsor's protocol ID
- 18-000077
- Status last verified
- Mar 2026
- First submitted
- 5 Feb 2019
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Pulp Regeneration for Root Canals by Autologous Tissue Transplantation
- ClinicalTrials.gov ID
- NCT03833401
- Acronym / sponsor ID
- 18-000077
- Conditions
- Dental Pulp Regeneration
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will involve two Arms; one serving as sham comparator, and the other arm serving as experimental (test) group.
| Arm | Type | Receives |
|---|---|---|
| Root canal revascularization | Sham comparator | Procedure: Root canal revascularizationRoot canal disinfection and revascularization without tissue transplantation. This will serve as control group. |
| Autologous tissue transplantation | Experimental | Procedure: Autologous tissue transplantationRoot canal disinfection will be performed and revascularization will be induced with autologous tissue transplantation. |
Who may qualify
- Ages
- 7 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous tissue transplantationRoot canal disinfection and revascularization with patient's own minced pulp tissues | Procedure or surgery | Autologous tissue transplantation |
| Root canal revascularizationRoot canal disinfection and revascularization without tissue transplantation | Procedure or surgery | Root canal revascularization |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Dental Pulp Regeneration
Active, not recruiting
Regenerative Root Canal Treatment of Immature Teeth Using Omega-3 Fatty Acids
Immature Permanent Teeth With Open Apex, Pulp Necrosis
Active, not recruiting
Effect of Different NanoScaffolds on Pulp Regeneration in Non-Vital Immature Permanent Teeth (Randomized Clinical Trial)
Necrotic Immature Permanent Incisors
Recruiting
Role of GTR on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication
Periapical Diseases, Endodontic Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mo Kang, DDS,PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous tissue transplantation and Root canal revascularization in people with Dental Pulp Regeneration, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in radiographic assessment for periapical inflammation (time frame: 6 months, 12 months, and 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.