NCT03544528: Regeneration

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

Status unknown NA Last updated 30 April 2021

What this trial tests

NA trial testing Regeneration in Dental Trauma in 34 participants. Status unknown.

Timeline

31 August 2017

Primary endpoint
31 December 2021

31 December 2023

Quick facts

Lead sponsor	Umeå University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	34
Start date	31 August 2017
Primary completion	31 December 2021
Estimated completion	31 December 2023
Sites	1 location across Sweden

Drugs / interventions tested

• Regeneration

Conditions studied

• Dental Trauma — all drugs for Dental Trauma →

Sponsor

Umeå University

Who can join

Adults 6 to 18, any sex, with Dental Trauma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. CBCT influences endodontic therapeutic decision-making in immature traumatized teeth with suspected pulp necrosis: a before-after study.
   Mota de Almeida FJ, Hassan D, Nasir Abdulrahman G, Brundin M, et al · · 2021 · cited 5× · PMID 34086502 · DOI 10.1259/dmfr.20200594