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

NCT03544528 | Unknown

• 1 other identifier: 2016-520-31M
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Trauma

Outcome Measures

Primary Outcomes (1)

• Volumetric Comparison of hard tissue formation

  3- dimensional analysis of regenerative treatment outcome

  18 months

Study Arms (2)

Regeneration

EXPERIMENTAL

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

Apexification

NO INTERVENTION

Traditional method. The application of Mineral Trioxide Aggregate (MTA) as an artificial apical barrier; also refer as the MTA apical plug method.

Interventions

Regeneration PROCEDURE

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.

Regeneration

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Umeå University

Umeå, Sweden

RECRUITING

MeSH Terms

Interventions

Regeneration

Intervention Hierarchy (Ancestors)

Biological Phenomena

Study Officials

• Nelly Romani Vestman, PhD

  Västerbottens Läns Landsting

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nelly Romani Vestman, PhD

CONTACT

0046907856070; nelly.romani.vestman@umu.se

Malin Brundin, PhD

CONTACT

malin.brundin@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: June 1, 2018
• Study Start: August 31, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)