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

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ClinicalTrials.gov Identifier: NCT01827098
Recruitment Status : Recruiting
First Posted : April 9, 2013
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Tatiana Botero, University of Michigan

January 7, 2013
April 9, 2013
June 20, 2017
October 2012
April 2019   (Final data collection date for primary outcome measure)
Absence of infection and inflammation. [ Time Frame: 12 and 24 months after the induction of blood clot ]
Same as current
Complete list of historical versions of study NCT01827098 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Clinical Study to Compare Two Revascularization Protocols to Treat Non-vital Teeth With Incomplete Root Formation
A Randomized Controlled Clinical Trial of Regenerative Protocols to Treat Immature Necrotic Teeth

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.

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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Dental Pulp Necrosis
  • Disorder of Tooth Development
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: 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.
    Intervention: Procedure: Endodontic Regeneration
  • Experimental: Immediate Induction
    Blood clot is induced after disinfection of the canal during the same visit. Endodontic regeneration is performed.
    Intervention: Procedure: Endodontic Regeneration

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Same as current
April 2019
April 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Years to 25 Years   (Child, Adult)
No
Contact: Tatiana M Botero, DDS, MS 734-764-1540 tbotero@umich.edu
Contact: Xianli Tang, DDS, MS 734-764-1540 xtang@umich.edu
United States
 
 
NCT01827098
HUM-00066353
Yes
Not Provided
Not Provided
Tatiana Botero, University of Michigan
University of Michigan
Not Provided
Principal Investigator: Tatiana M Botero, DDS, MS University of Michigan
University of Michigan
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP