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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03683862
Other study ID # 341/10.07.17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2018
Est. completion date March 5, 2019

Study information

Verified date March 2019
Source University of Athens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 77
Est. completion date March 5, 2019
Est. primary completion date March 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Greece School of Dentistry, Department of Orthodontics, National and Kapodistrian University of Athens Athens

Sponsors (1)

Lead Sponsor Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compliance of retainer wear Compliance of retainer wear at 3 months, as expressed by average hours of daily wear (with the aid of TheraMon) 3 months
Secondary Compliance of retainer wear Compliance of retainer wear at 1 month, as expressed by average hours of daily wear (with the aid of TheraMon) 1 month
Secondary Association between objective compliance assessment and diary reported hours Association between objective compliance assessment (TheraMon) and diary reported hours (by patient) 3 months
Secondary Association between objective compliance assessment and diary reported hours Association between objective compliance assessment (TheraMon) and diary reported hours (by patient) 1 month