Endodontic Regenerative Procedure for Immature Non-vital Teeth

NCT ID: NCT03425123

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2023-01-31

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.

Conditions

Tooth, Nonvital

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

REP Group

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.

Group Type: EXPERIMENTAL

Regenerative Endodontic Procedure (REP)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sami Chogle, BDS DMD MSD

Role: STUDY_DIRECTOR

Henry M Goldman School of Dental Medicine

Locations

Henry M Goldman School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-37079

Identifier Type: -

Identifier Source: org_study_id