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A Clinical Study to Compare Two Revascularization Protocols to Treat Non-vital Teeth With Incomplete Root Formation

This study is currently recruiting participants.
Verified June 2017 by Tatiana Botero, University of Michigan
Sponsor:
ClinicalTrials.gov Identifier:
NCT01827098
First Posted: April 9, 2013
Last Update Posted: June 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tatiana Botero, University of Michigan
  Purpose

Both methods tested in this study disinfect the non-vital root canals and induce blood clot formation inside the root canal. One method places calcium hydroxide inside the root canal after disinfection and the blood clot is induced four weeks later.

The other method performs disinfection and induction of blood clot in one appointment. The investigators hypothesize that both methods will obtain the same success rate in eliminating infection, increase in root length and canal walls thickness.


Condition Intervention Phase
Dental Pulp Necrosis Disorder of Tooth Development Procedure: Endodontic Regeneration Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial of Regenerative Protocols to Treat Immature Necrotic Teeth

Further study details as provided by Tatiana Botero, University of Michigan:

Primary Outcome Measures:
  • Absence of infection and inflammation. [ Time Frame: 12 and 24 months after the induction of blood clot ]

Secondary Outcome Measures:
  • Changes in root length and canal wall width [ Time Frame: Baseline and 12 months after the induction of blood clot ]
  • Changes in root length and canal wall width [ Time Frame: Baseline and 24 months after the induction of blood clot ]

Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Delayed induction
The root canal is disinfected and calcium hydroxide is placed in the canal. Blood clot is induced in the canal 4 weeks later. Endodontic Regeneration is performed.
Procedure: Endodontic Regeneration
Blood clot formation is induced in the root canal after disinfection. Collagen material is placed over the clot. The canal access is sealed with white MTA and glass ionomer restoration. Permanent restoration is placed 3 months later on top of the MTA.
Experimental: Immediate Induction
Blood clot is induced after disinfection of the canal during the same visit. Endodontic regeneration is performed.
Procedure: Endodontic Regeneration
Blood clot formation is induced in the root canal after disinfection. Collagen material is placed over the clot. The canal access is sealed with white MTA and glass ionomer restoration. Permanent restoration is placed 3 months later on top of the MTA.

Detailed Description:
Collagen is placed on top of the blood clot, followed by white MTA. Glass ionomer is used to seal the access to the canal, which will be replaced by a permanent restoration 3 months later.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy or having a mild systemic disease (ASA Physical Status 1 or 2), with no contraindications to the treatment.
  • Cooperative.
  • Clinical diagnosis of pulp necrosis based on cold test, electric pulp test as well as an identified cause of pulp necrosis such as caries, deep restorations, dental anomalies, history of trauma, associated with radiographic and/or clinic signs of periapical lesion.
  • Open apex with a diameter of at least 1mm. For teeth with more than one apical foramen, at least one foramen needs to be 1mm wide.
  • Tooth is restorable and periodontally stable.

Exclusion Criteria:

  • Pregnancy.
  • Evidence of pathological external or internal root resorption, root fracture or ankylosis.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827098


Contacts
Contact: Tatiana M Botero, DDS, MS 734-764-1540 tbotero@umich.edu
Contact: Xianli Tang, DDS, MS 734-764-1540 xtang@umich.edu

Locations
United States, Michigan
Graduate Endodontic Clinic Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Tatiana M Botero, DDS, MS    734-764-1540    tbotero@umich.edu   
Principal Investigator: Tatiana M Botero, DDS, MS         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Tatiana M Botero, DDS, MS University of Michigan
  More Information

Additional Information:
Publications:

Responsible Party: Tatiana Botero, Clinical Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01827098     History of Changes
Other Study ID Numbers: HUM-00066353
First Submitted: January 7, 2013
First Posted: April 9, 2013
Last Update Posted: June 20, 2017
Last Verified: June 2017

Keywords provided by Tatiana Botero, University of Michigan:
Immature teeth
Calcium Hydroxide
Blood clot
Revascularization
Revitalization

Additional relevant MeSH terms:
Necrosis
Dental Pulp Necrosis
Tooth Diseases
Pathologic Processes
Dental Pulp Diseases
Stomatognathic Diseases