Endodontic Regenerative Procedure for Immature Non-vital Teeth

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.

Study Overview

• Status: Withdrawn
• Conditions: Tooth, Nonvital
• Intervention / Treatment: Other: Regenerative Endodontic Procedure (REP)

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Henry M Goldman School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
periradicular bone infection	Assess and document any signs/symptoms of infection at the second visit	1-4 weeks after first visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Study Director: Sami Chogle, BDS DMD MSD, Henry M Goldman School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2019
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (ACTUAL): February 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• 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
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: H-37079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No