Tooth, NonvitalNCT03425123
Endodontic Regenerative Procedure for Immature Non-vital Teeth
A study testing Regenerative Endodontic Procedure (REP) in people with Tooth, Nonvital, run by Boston University at 1 site in United States.
Trial summary
In this clinical trial the investigators will evaluate an alternate treatment option, which was developed for teeth with incomplete roots, called Regenerative Endodontic Procedure (REP). Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Tooth, Nonvital
- What is being tested?
- Regenerative Endodontic Procedure (REP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2019to Jan 2023
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects followed prospectively
- 7-18 years old
- salvageable permanent non-vital tooth with immature apex whether anterior or posterior
- receiving dental care at the Henry M. Goldman School of Dentistry Historical controls
- 7-18 year old
- salvageable permanent non-vital tooth with immature apex whether anterior or posterior
- received care and has accessible records at the Henry M. Goldman School of Dentistry
- had either the Calcium hydroxide apexification or MTA apexification between 2007 and 2017
Who cannot join
- allergic to medications necessary to complete procedure
- health status not in: a) ASA-1 no organic pathology or patients in whom the pathological process is localized and does not cause any systemic disturbance or abnormality; nor b) ASA 2 A moderate but definite systemic disturbance, caused either by the condition that is to be treated or surgical intervention or which is caused by other existing pathological processes
- history of dental trauma within 6 months due to possibility of internal and external root resorption.
- if tooth pulp space is needed for post/core final restoration
- pregnancy in female subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry M Goldman School of Dental Medicine
Boston, Massachusetts, 02118
About this study
In this clinical trial the investigators will evaluate an alternate treatment option, which was developed for teeth with incomplete roots, called Regenerative Endodontic Procedure (REP). This treatment works by harnessing the blood clot formed within the root canal from tissues surrounding the root as a scaffold for stem cells. These cells could help to increase the thickness and length of the root canal walls resulting in root end maturation.
Results from the 50 participants who will receive the REP treatment will be compared with findings with historical data.
Read the detailed description
All participants will be prospectively assigned to the REP treatment group. Results from the treatment group will be compared to historical controls of all subjects treated by Ca(OH)2 or MTA apexification in the last 10 years (2007-2017) at the Boston University Henry M Goldman School of Dental Medicine.
All materials used in this protocol are FDA approved and commercially available for similar applications. This study does not seek a new use or application of any materials, instead recommendations of the American Association of Endodontists (AAE) will be followed to evaluate outcomes associated with the REP compare to the standard of care Ca(OH)2 or MTA apexification.
The overall objective for this research is the elimination of any clinical symptoms and the evidence of bony healing as examined by radiographs.
Other objectives include increased root wall thickness and/or increased root length and positive response to vitality testing, which if achieved, could indicate a more organized vital pulp tissue.
- Conditions
- Tooth, Nonvital
- Being tested
- Regenerative Endodontic Procedure (REP)
- Keywords
- Regenerative endodontic procedure (REP), Mineral Trioxide Aggregate (MTA) apexification, Calcium Hydroxide -Ca(OH)2, Permanent non-vital tooth, Children 7-18 years of age
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative Endodontic Procedure (REP)Other
Regenerative Endodontic Procedure (REP) involves disinfection of the root canal with the use of acombination of three antibiotics including ciprofloxacin, metronidazole, minocycline. At the second visit, the patient is evaluated for resolution of signs or symptoms of an acute infection and if none then bleeding is induced, the site covered with a plug and the patient is evaluated at follow up.
| Study group | Role | What they receive |
|---|---|---|
| REP Group | Experimental | All participants in this single arm study will receive Regenerative Endodontic Procedure (REP). It regenerates the root tip on recently erupted permanent teeth that did not complete root development due to pulp infection and necrosis by allowing cells to migrate from the surrounding periapical tissue and enter the pulp space. Cells contained within the intentional bleeding create at the root tip help in root completion as well as increasing the thickness of the canal walls over up to two years following the procedure. Receives: Other: Regenerative Endodontic Procedure (REP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
periradicular bone healing
Bone healing will be determined by calculating the difference in the bone thickness in millimeters comparing baseline to 24 months on radiographs
Measured: 24 months
periradicular bone infection
Assess and document any signs/symptoms of infection at the second visit
Measured: 1-4 weeks after first visit
Secondary outcomes (6)
tooth root thickness at 12 months
The tooth root thickness will be measured in millimeters, comparing the pre-procedure radiographs and Cone-Beam-Computed Tomography scans (CBCT) to radiographs and CBCT at 12 months
Measured: 12 months
tooth root thickness at 24 months
The tooth root thickness will be measured in millimeters, comparing the pre-procedure radiographs and Cone-Beam-Computed Tomography scans (CBCT) to radiographs and CBCT at 24 months
Measured: 24 months
tooth root length at 12 months
The tooth root length will be measured in millimeters, comparing the pre-procedure radiographs and Cone-Beam-Computed Tomography scans (CBCT) to radiographs and CBCT at 12 months
Measured: 12 months
tooth root length at 24 months
The tooth root length will be measured in millimeters, comparing the pre-procedure radiographs and Cone-Beam-Computed Tomography scans (CBCT) to radiographs and CBCT at 24 months
Measured: 24 months
tooth vitality at 12 months
A pain response to hot/cold and electrical pulp tester will be done to test the vitality of the tooth pulp at 12 months
Measured: 12 months
tooth vitality at 24 months
A pain response to hot/cold and electrical pulp tester will be done to test the vitality of the tooth pulp at 24 months
Measured: 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 2018
- Study startJun 2019 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: The study was not started due to the lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth, NonvitalStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sami Chogle, BDS DMD MSD, Study director, Henry M Goldman School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425123
- Sponsor's protocol ID
- H-37079
- Status last verified
- May 2019
- First submitted
- 1 Feb 2018
- Last updated
- 3 May 2019
- 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 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endodontic Regenerative Procedure for Immature Non-vital Teeth
- ClinicalTrials.gov ID
- NCT03425123
- Acronym / sponsor ID
- H-37079
- Conditions
- Tooth, Nonvital
- Keywords
- Regenerative endodontic procedure (REP), Mineral Trioxide Aggregate (MTA) apexification, Calcium Hydroxide -Ca(OH)2, Permanent non-vital tooth, Children 7-18 years of age
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not started due to the lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 7 Feb 2018 (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.
In this clinical trial the investigators will evaluate an alternate treatment option, which was developed for teeth with incomplete roots, called Regenerative Endodontic Procedure (REP). This treatment works by harnessing the blood clot formed within the root canal from tissues surrounding the root as a scaffold for stem cells. These cells could help to increase the thickness and length of the root canal walls resulting in root end maturation.
Results from the 50 participants who will receive the REP treatment will be compared with findings with historical data.
Detailed description
All participants will be prospectively assigned to the REP treatment group. Results from the treatment group will be compared to historical controls of all subjects treated by Ca(OH)2 or MTA apexification in the last 10 years (2007-2017) at the Boston University Henry M Goldman School of Dental Medicine.
All materials used in this protocol are FDA approved and commercially available for similar applications. This study does not seek a new use or application of any materials, instead recommendations of the American Association of Endodontists (AAE) will be followed to evaluate outcomes associated with the REP compare to the standard of care Ca(OH)2 or MTA apexification.
The overall objective for this research is the elimination of any clinical symptoms and the evidence of bony healing as examined by radiographs.
Other objectives include increased root wall thickness and/or increased root length and positive response to vitality testing, which if achieved, could indicate a more organized vital pulp tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REP Group | Experimental | Other: Regenerative Endodontic Procedure (REP)All participants in this single arm study will receive Regenerative Endodontic Procedure (REP). It regenerates the root tip on recently erupted permanent teeth that did not complete root development due to pulp infection and necrosis by allowing cells to migrate from the surrounding periapical tissue and enter the pulp space. Cells contained within the intentional bleeding create at the root tip help in root completion as well as increasing the thickness of the canal walls over up to two years following the procedure. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Subjects followed prospectively
- 7-18 years old
- salvageable permanent non-vital tooth with immature apex whether anterior or posterior
- receiving dental care at the Henry M. Goldman School of Dentistry Historical controls
- 7-18 year old
Key exclusion criteria (5 listed)
- allergic to medications necessary to complete procedure
- health status not in: a) ASA-1 no organic pathology or patients in whom the pathological process is localized and does not cause any systemic disturbance or abnormality; nor b) ASA 2 A moderate but definite systemic disturbance, caused either by the condition that is to be treated or surgical intervention or which is caused by other existing pathological processes
- history of dental trauma within 6 months due to possibility of internal and external root resorption.
- if tooth pulp space is needed for post/core final restoration
- pregnancy in female subjects
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 |
|---|---|---|
| Regenerative Endodontic Procedure (REP)Regenerative Endodontic Procedure (REP) involves disinfection of the root canal with the use of acombination of three antibiotics including ciprofloxacin, metronidazole, minocycline. At the second visit, the patient is evaluated for resolution of signs or symptoms of an acute infection and if none then bleeding is induced, the site covered with a plug and the patient is evaluated at follow up. | Other | REP Group |
Primary outcome
periradicular bone healing
Time frame: 24 months
Bone healing will be determined by calculating the difference in the bone thickness in millimeters comparing baseline to 24 months on radiographs
periradicular bone infection
Time frame: 1-4 weeks after first visit
Assess and document any signs/symptoms of infection at the second visit
6 secondary outcomes
tooth root thickness at 12 months
Time frame: 12 months
tooth root thickness at 24 months
Time frame: 24 months
tooth root length at 12 months
Time frame: 12 months
tooth root length at 24 months
Time frame: 24 months
tooth vitality at 12 months
Time frame: 12 months
tooth vitality at 24 months
Time frame: 24 months
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 3 May 2019.
- Individual participant dataSharing planned: No
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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.
Sami Chogle, BDS DMD MSD study director
Henry M Goldman School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenerative Endodontic Procedure (REP) in people with Tooth, Nonvital, run by Boston University 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 8 inclusion and 5 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 3 May 2019. 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. 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?
periradicular bone healing (time frame: 24 months). The study lists 2 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 3 May 2019.