Essix Retainer vs Hawley Retainer

NCT ID: NCT01583933

Last Updated: 2012-04-27

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-05-31

Brief Summary

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There are several factors involved in the decision and the retention plan, such as occlusion, patient age, etiology of malocclusion, the speed of the correction, the length of the cusps and health of the tissues involved, relationships inclined planes, size of the arches, harmony of the arches, muscle pressure, interdental proximal contact, cell metabolism and atmospheric pressure. Given these concepts, we need to find grounds to enable decision making with respect to the retainer that offers the best features of containment and stability.

Detailed Description

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This study aims to assess the stability of tooth position and occlusal retention during treatment with two types of retainers, Essix type retainer and the retainer plate type Hawley in individuals who have completed their growth ending orthodontic treatment at the Faculty of Dentistry University of Antioquia and CES University Medellín

Conditions

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Dental and Occlusal Stability

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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Essix retainer

Group Type EXPERIMENTAL

Essix retainer

Intervention Type DEVICE

The essix retainer is made in a thermoforming copolyester 0.75mm (0.30 ", it processed gives a thickness of 0.015" approximately. Retainer will be used molar to molar. subjects in this arm will have this retainer for 24 hours a day for 6 months, they won´t have this device for food intake.

Hawley retainer

Hawley retainer is a device composed of an acrylic base with built-in hooks and a labial arch wire 0.022 "x0.036" and attached to the teeth. Its metal component consists of two adams hooks positioned from the first permanent molar right to left, a labial bow that progresses from lingual superface to distal of canine to integrate with the acrylic base.

Group Type ACTIVE_COMPARATOR

Hawley retainer

Intervention Type DEVICE

subjects in this arm will have the retainer for 24 hours a day for 6 months. During food intake they won´t have this device.

Interventions

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Essix retainer

The essix retainer is made in a thermoforming copolyester 0.75mm (0.30 ", it processed gives a thickness of 0.015" approximately. Retainer will be used molar to molar. subjects in this arm will have this retainer for 24 hours a day for 6 months, they won´t have this device for food intake.

Intervention Type DEVICE

Hawley retainer

subjects in this arm will have the retainer for 24 hours a day for 6 months. During food intake they won´t have this device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who have stabilized their growth between 16 and 40 who have completed orthodontic treatment and initiate retention treatment
* Who have agreed to participate in the study if elected and to sign informed consent
* Residing in the metropolitan area of Medellin and have the opportunity to attend recall appointments

Exclusion Criteria

* Periodontal status deteriorated
* missing teeth
* Cleft lip and palate
* History of orthognathic surgery
* History of dental or skeletal open bite
* Presence of some habit oral tongue thrusting, mouth breathing, thumb sucking even after termination of orthodontic treatment
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Antioquia

OTHER

Sponsor Role collaborator

CES University

OTHER

Sponsor Role lead

Responsible Party

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Angela Maria Segura Cardona

Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CES University

Medellín, Antioquia, Colombia

Site Status RECRUITING

Countries

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Colombia

Central Contacts

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Sandra Gómez, Orthodontist

Role: CONTACT

574 3127492

Angela María Segura Cardona, PhD in Epidemiology

Role: CONTACT

574 4440555

Facility Contacts

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Angela Segura

Role: primary

Other Identifiers

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SFHA-02

Identifier Type: -

Identifier Source: org_study_id

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