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

Dental Trauma Clinical Trial

— Regeneration  

Official title:

Necrotic Immature Teeth Treated by Regeneration or Apexification: A 3-dimensional Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03544528
• Other study ID #: 2016-520-31M
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2021
• Source: Umeå University
• Contact: Nelly Romani Vestman, PhD
• Phone: 0046907856070
• Email: nelly.romani.vestman[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Trauma

Intervention

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.

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volumetric Comparison of hard tissue formation	3- dimensional analysis of regenerative treatment outcome	18 months