NCT03425123

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

3.6 years

First QC Date

February 1, 2018

Last Update Submit

May 1, 2019

Conditions

Tooth, Nonvital

Keywords

Regenerative endodontic procedure (REP)Mineral Trioxide Aggregate (MTA) apexificationCalcium Hydroxide -Ca(OH)2Permanent non-vital toothChildren 7-18 years of age

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • tooth root thickness at 12 months

    12 months

  • tooth root thickness at 24 months

    24 months

  • tooth root length at 12 months

    12 months

  • tooth root length at 24 months

    24 months

  • tooth vitality at 12 months

    12 months

  • +1 more secondary outcomes

Study Arms (1)

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.

Other: Regenerative Endodontic Procedure (REP)

Interventions

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.

REP Group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects followed prospectively
  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry M Goldman School of Dental Medicine

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Sami Chogle, BDS DMD MSD

    Henry M Goldman School of Dental Medicine

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 7, 2018

Study Start

June 1, 2019

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

May 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)