Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers

NCT ID: NCT03683862

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2019-03-05

Brief Summary

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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).

Detailed Description

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Conditions

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Orthodontic Retention Compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

orthodontic appliance

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

orthodontic appliance

Intervention Type OTHER

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

Interventions

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orthodontic appliance

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Despina Koletsi

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgia Vagdouti

Role: PRINCIPAL_INVESTIGATOR

School of Dentistry, National and Kapodistrian University of Athens

Locations

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

Athens, , Greece

Site Status

Countries

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Greece

References

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Vagdouti G, Karvouni E, Bitsanis E, Koletsi D. Objective evaluation of compliance after orthodontic treatment using Hawley or vacuum-formed retainers: A 2-center randomized controlled trial over a 3-month period. Am J Orthod Dentofacial Orthop. 2019 Dec;156(6):717-726.e2. doi: 10.1016/j.ajodo.2019.07.008.

Reference Type DERIVED
PMID: 31784005 (View on PubMed)

Other Identifiers

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341/10.07.17

Identifier Type: -

Identifier Source: org_study_id

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