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Cone-beam Computed Tomographic (CBCT) and Regenerative Endodontic Treatment. (Regeneration)

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.
 
ClinicalTrials.gov Identifier: NCT03544528
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Umeå University

Study Description
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Brief Summary:

Dental trauma injuries during childhood may have an adverse impact on oral health throughout life. If trauma injuries causes pulpal necrosis, then the root stop forming. These teeth have consequently a questionable long-term survival.

Dental management of necrotic teeth with aberrant root formation represents a challenging clinical situation. The classical approach for treating these teeth includes apexification. Both apexification with Calcium hydroxide and MTA do not achieve the goals of continued root development or restoration of pulp tissue functionality.

In the last decades, a biological based approach referred as "revascularization", or "regeneration" has emerged as a biological treatment for necrotic pulps with aberrant root development. This treatment aims to regenerate pulp-like tissue within the root canal space after inducing an influx of stem cells from the apical papilla that results in reestablishment of pulp protective functions. There is evidence supporting the regeneration potential of dental tissues after regenerative endodontic treatment. However, root formation in traumatized immature teeth seems variable.

The overall goal of this study is to gain knowledge about the treatment of immature necrotic teeth in young individuals due to dental trauma. The primary goal is to compare volumetric hard tissue formation between the MTA apexification and the regeneration treatment.


Condition or disease Intervention/treatment Phase
Dental Trauma Procedure: Regeneration Not Applicable

Detailed Description:
A randomized controlled trial, employing 34 young individuals aged 6-18 years, with immature necrotic teeth will be included. The test group will be treated by the regeneration procedure and the control group by the application of an MTA-plug. Clinical and low-dose cone-beam computed tomography scans (preoperatively and at 18-months follow-up) will be retrieved. Clinical data with information about tooth survival, absents of symptoms, resolution of infection and root development will be taken at every session.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Necrotic Immature Teeth Treated by Regeneration or Apexification: A 3-dimensional Analysis
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Regeneration
This treatment aims to regenerate pulp-like tissue within the root canal space after inducing an influx of stem cells from the apical papilla that results in reestablishment of pulp protective functions.
 Procedure: Regeneration
Apical bleeding will be induced by passing a hand instrument beyond the apical foramen to allow blood filling in the canal. Mineral trioxide aggregate will be placed directly over the coagulated blood clot.
No Intervention: Apexification
Traditional method. The application of Mineral Trioxide Aggregate (MTA) as an artificial apical barrier; also refer as the MTA apical plug method.


Outcome Measures
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Primary Outcome Measures :
  1. Volumetric Comparison of hard tissue formation [ Time Frame: 18 months ]
    3- dimensional analysis of regenerative treatment outcome


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Immature teeth and confirmed pulp necrosis caused by dental trauma.
  • Teeth with apical opening larger that 1mm observed in the initial CBCT.

Exclusion Criteria:

  • Extensive loss of coronal tissue that require restoration with a post that will occupy the space required for blood clot formation.
  • Patients who had received antibiotic treatment during the previous 3 months.
Contacts and Locations
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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): NCT03544528


Contacts
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Contact: Nelly Romani Vestman, PhD 0046907856070 nelly.romani.vestman@umu.se
Contact: Malin Brundin, PhD malin.brundin@umu.se

Locations
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Sweden
Umeå University Recruiting
Umeå, Sweden
Contact: Nelly Romani Vestman, PhD       nelly.romani.vestman@umu.se   
Contact: Malin Brundin, PhD       mail.brundin@umu.se   
Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Nelly Romani Vestman, PhD Västerbottens Läns Landsting
More Information
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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT03544528    
Other Study ID Numbers: 2016-520-31M
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No