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Orthodontic Treatment in Adolescents With Crowding and Displaced Teeth

NCT05664282 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2022-12-23

No results posted yet for this study

Summary

The purpose is to fill knowledge gaps identified for orthodontic treatment using a novel study design that has not been implemented in the dental field or in orthodontics. The study design comprises an analysis, where outcomes of two techniques are assessed at several efficacy levels by different methods. Moreover, the project is designed to include a longtime follow-up that is unique in orthodontic treatment. The aim is to compare two techniques with buccally fixed appliance in a multicenter RCT of adolescents aged 12 to 17 years with crowding and tooth displacement. In the intervention group, patients will be treated with a self-ligating bracket system, and in the control group with a conventional bracket system. Outcomes will be assessed from the clinical, patients' and economic perspectives as:

* Tooth alignment, function and adverse side effects
* Patients' perception of pain, function and quality of life
* Cost-effectiveness.

Conditions

  • Crowding, Tooth
  • Orthodontic

Interventions

DEVICE

Damon self-ligating brackets

DEVICE

Victory self-ligating brackets

Sponsors & Collaborators

  • Malmö University

    lead OTHER

Principal Investigators

  • Liselotte Paulsson · Malmö University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664282 on ClinicalTrials.gov