Working… Menu

Essix Retainer vs Hawley Retainer (retainer)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01583933
Recruitment Status : Unknown
Verified April 2012 by Angela Maria Segura Cardona, CES University.
Recruitment status was:  Recruiting
First Posted : April 24, 2012
Last Update Posted : April 27, 2012
Universidad de Antioquia
Information provided by (Responsible Party):
Angela Maria Segura Cardona, CES University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental and Occlusal Stability Device: Essix retainer Device: Hawley retainer Phase 3

Detailed Description:
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2011
Actual Primary Completion Date : January 2012
Estimated Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: Essix retainer Device: 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.

Active Comparator: 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.
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.

Primary Outcome Measures :
  1. Dental stability [ Time Frame: Up to 6 months ]
    Dental stability will be assessed like this, models: rotation of central and lateral incisor, canine, first and second premolar, first molar on each side and each arch; and cephalometric analysis: SN-upper central incisive, FK-upper central incisive, palate plane-upper central incisive, interincisal angle, mandibular plane-lower central incisive; vertical distances: palate plane-upper central incisive, palate plane-first upper molar, mandibular plane-lower central incisive, mandibular plane-first lower molar; horizontal distances: A-Pogonion upper and lower central incisive.

Secondary Outcome Measures :
  1. Occlusal stability [ Time Frame: Up to 6 months ]

    Occlusal stability will be measured at the beginning and end of study through clinic exam and study models.

    Clinic exam: canine relations right and left, molar relations left and right, overjet, overbite, presence of anterior open bite, presence of posterior open bite.

    Models: upper and lower arch, upper and lower intercanine distance, upper and lower distance interpremolar, upper and lower intermolar distance.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01583933

Layout table for location contacts
Contact: Sandra Gómez, Orthodontist 574 3127492
Contact: Angela María Segura Cardona, PhD in Epidemiology 574 4440555

Layout table for location information
CES University Recruiting
Medellín, Antioquia, Colombia
Contact: Angela Segura   
Sponsors and Collaborators
CES University
Universidad de Antioquia

Layout table for additonal information
Responsible Party: Angela Maria Segura Cardona, Research, CES University Identifier: NCT01583933     History of Changes
Other Study ID Numbers: SFHA-02
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012
Keywords provided by Angela Maria Segura Cardona, CES University:
Dental stability
Occlusal stability
Additional relevant MeSH terms:
Layout table for MeSH terms
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents