Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers (OrthoComply)

March 26, 2019 updated by: Despina Koletsi, University of Athens

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11527 Goudi
        • School of Dentistry, Department of Orthodontics, National and Kapodistrian University of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thermoplastic Retainer
Impressions of the upper arch will be taken at the day of bracket debonding and the retainer will be delivered in 24 hours. TheraMon microchip will be embedded within the appliance and patients will be instructed to wear the appliance 24 hours/ day.
Other: orthodontic appliance
Orthodontic device for retention in the upper arch, after the end of orthodontic treatment
Active Comparator: Hawley Retainer
Impressions of the upper arch will be taken at the day of bracket debonding and the retainer will be delivered in 24 hours. TheraMon microchip will be embedded within the appliance and patients will be instructed to wear the appliance 24 hours/ day.
Other: orthodontic appliance
Orthodontic device for retention in the upper arch, after the end of orthodontic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 month
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 months
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)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Investigators

  • Principal Investigator: Georgia Vagdouti, School of Dentistry, National and Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2018

Primary Completion (Actual)

March 5, 2019

Study Completion (Actual)

March 5, 2019

Study Registration Dates

First Submitted

September 23, 2018

First Submitted That Met QC Criteria

September 24, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 341/10.07.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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