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

NCT ID: NCT03544528

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Regeneration

Intervention Type 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.

Apexification

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nelly Romani Vestman, PhD

Role: PRINCIPAL_INVESTIGATOR

Västerbottens Läns Landsting

Locations

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Umeå University

Umeå, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Nelly Romani Vestman, PhD

Role: CONTACT

0046907856070

Malin Brundin, PhD

Role: CONTACT

Facility Contacts

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Nelly Romani Vestman, PhD

Role: primary

Malin Brundin, PhD

Role: backup

Other Identifiers

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2016-520-31M

Identifier Type: -

Identifier Source: org_study_id

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