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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Tatiana Botero, University of Michigan
ClinicalTrials.gov Identifier:
NCT01827098
First received: January 7, 2013
Last updated: June 10, 2013
Last verified: June 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial of Regenerative Protocols to Treat Immature Necrotic Teeth

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Absence of infection and inflammation. [ Time Frame: 12 and 24 months after the induction of blood clot ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in root length and canal wall width [ Time Frame: Baseline and 12 months after the induction of blood clot ] [ Designated as safety issue: No ]
  • Changes in root length and canal wall width [ Time Frame: Baseline and 24 months after the induction of blood clot ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2014 (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

Ages Eligible for Study:   6 Years to 25 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 7, 2013
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 14, 2014