Essix Retainer vs Hawley Retainer (retainer)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by CES University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by (Responsible Party):
Angela Maria Segura Cardona, CES University
ClinicalTrials.gov Identifier:
NCT01583933
First received: April 23, 2012
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Dental and Occlusal Stability
Device: Essix retainer
Device: Hawley retainer
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PHASE 3 STUDY OF THE EFFECTIVITY OF TWO RETAINERS IN THE DENTAL AND OCCLUSAL STABILITY

Further study details as provided by CES University:

Primary Outcome Measures:
  • Dental stability [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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:
  • Occlusal stability [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 46
Study Start Date: September 2011
Estimated Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583933

Contacts
Contact: Sandra Gómez, Orthodontist 574 3127492 sandraligomez11@gmail.com
Contact: Angela María Segura Cardona, PhD in Epidemiology 574 4440555 asegura@ces.edu.co

Locations
Colombia
CES University Recruiting
Medellín, Antioquia, Colombia
Contact: Angela Segura       asegura@ces.edu.co   
Sponsors and Collaborators
CES University
Universidad de Antioquia
  More Information

No publications provided

Responsible Party: Angela Maria Segura Cardona, Research, CES University
ClinicalTrials.gov Identifier: NCT01583933     History of Changes
Other Study ID Numbers: SFHA-02
Study First Received: April 23, 2012
Last Updated: April 26, 2012
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by CES University:
Dental stability
Occlusal stability
Retainers

ClinicalTrials.gov processed this record on August 28, 2014