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Completed

NCT Number: NCT03683862

Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers

This study aims to assess adolescent's compliance after the end of orthodontic treatment using either thermoplastic or Hawley retainers in the upper arch, with the aid of TheraMon microsensor (MC Technology GmbH).

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Key information

Conditions

Orthodontic Retention Compliance Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, Department of Orthodontics, National and Kapodistrian University of Athens

Athens, 11527 Goudi, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients that have completed orthodontic treatment (are at stage of debonding) with fixed appliances in the upper and lower arch
  • age 12- 18

Exclusion criteria

  • systematic diseases
  • craniofacial anomalies (clefts, etc)
  • handicapped patients with problems of compliance
  • pregnant women
  • previous orthodontic treatment or compromise orthodontic treatment

Treatment and study plan

orthodontic appliance

Other

Orthodontic device for retention in the upper arch, after the end of orthodontic treatment

Primary outcomes

  1. Compliance of retainer wear

    Time frame: 3 months

    Compliance of retainer wear at 3 months, as expressed by average hours of daily wear (with the aid of TheraMon)

Secondary outcomes

  1. Compliance of retainer wear

    Time frame: 1 month

    Compliance of retainer wear at 1 month, as expressed by average hours of daily wear (with the aid of TheraMon)

  2. Association between objective compliance assessment and diary reported hours

    Time frame: 3 months

    Association between objective compliance assessment (TheraMon) and diary reported hours (by patient)

  3. Association between objective compliance assessment and diary reported hours

    Time frame: 1 month

    Association between objective compliance assessment (TheraMon) and diary reported hours (by patient)

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study title

Objective Evaluation of Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers: A Randomized Controlled Trial

Acronym: OrthoComply

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2018
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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