Back to results

Endodontic Regenerative Procedure for Immature Non-vital Teeth

Primary Purpose

Tooth, Nonvital

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Regenerative Endodontic Procedure (REP)

About this trial

This is an interventional treatment trial for Tooth, Nonvital focused on measuring Regenerative endodontic procedure (REP), Mineral Trioxide Aggregate (MTA) apexification, Calcium Hydroxide -Ca(OH)2, Permanent non-vital tooth, Children 7-18 years of age

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Henry M Goldman School of Dental Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

REP Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

periradicular bone infection

Assess and document any signs/symptoms of infection at the second visit

Secondary Outcome Measures

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

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

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

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

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

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

Full Information

NCT ID

NCT03425123

First Posted

February 1, 2018

Last Updated

May 1, 2019

Sponsor

Boston University

1. Study Identification

Unique Protocol Identification Number

NCT03425123

Brief Title

Endodontic Regenerative Procedure for Immature Non-vital Teeth

Official Title

Endodontic Regenerative Procedure for Immature Non-vital Teeth

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Withdrawn

Why Stopped

The study was not started due to the lack of funding.

Study Start Date

June 2019 (Anticipated)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

REP Group

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Regenerative Endodontic Procedure (REP)

Intervention Description

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.

Primary Outcome Measure Information:

Title

periradicular bone healing

Description

Bone healing will be determined by calculating the difference in the bone thickness in millimeters comparing baseline to 24 months on radiographs

Time Frame

24 months

Title

periradicular bone infection

Description

Assess and document any signs/symptoms of infection at the second visit

Time Frame

1-4 weeks after first visit

Secondary Outcome Measure Information:

Title

tooth root thickness at 12 months

Description

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

Time Frame

12 months

Title

tooth root thickness at 24 months

Description

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

Time Frame

24 months

Title

tooth root length at 12 months

Description

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

Time Frame

12 months

Title

tooth root length at 24 months

Description

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

Time Frame

24 months

Title

tooth vitality at 12 months

Description

A pain response to hot/cold and electrical pulp tester will be done to test the vitality of the tooth pulp at 12 months

Time Frame

12 months

Title

tooth vitality at 24 months

Description

A pain response to hot/cold and electrical pulp tester will be done to test the vitality of the tooth pulp at 24 months

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sami Chogle, BDS DMD MSD

Organizational Affiliation

Henry M Goldman School of Dental Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Henry M Goldman School of Dental Medicine

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Endodontic Regenerative Procedure for Immature Non-vital Teeth

We'll reach out to this number within 24 hrs