Tooth, Nonvital Clinical Trial
Official title:
Endodontic Regenerative Procedure for Immature Non-vital Teeth
NCT number | NCT03425123 |
Other study ID # | H-37079 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2019 |
Est. completion date | January 2023 |
Verified date | May 2019 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2023 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 18 Years |
Eligibility |
Inclusion Criteria: 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Henry M Goldman School of Dental Medicine | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 24 months | |
Primary | periradicular bone infection | Assess and document any signs/symptoms of infection at the second visit | 1-4 weeks after first visit | |
Secondary | 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 | 12 months | |
Secondary | 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 | 24 months | |
Secondary | 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 | 12 months | |
Secondary | 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 | 24 months | |
Secondary | 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 | 12 months | |
Secondary | 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 | 24 months |
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