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Essix Retainer vs Hawley Retainer (retainer)

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by (Responsible Party):
Angela Maria Segura Cardona, CES University

Tracking Information
First Submitted Date  ICMJE April 23, 2012
First Posted Date  ICMJE April 24, 2012
Last Update Posted Date April 27, 2012
Study Start Date  ICMJE September 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2012)
Dental stability [ Time Frame: Up to 6 months ]
Dental stability will be measured at the beginning and end of study through clinic exam, study models and measures in the cephalic lateral radiograph.
Change History Complete list of historical versions of study NCT01583933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2012)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2012)
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. The hypothesis is that tooth and occlusal position is stable over time differently to treatment with the type Essix retainer and Hawley retainer
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Essix Retainer vs Hawley Retainer
Official Title  ICMJE PHASE 3 STUDY OF THE EFFECTIVITY OF TWO RETAINERS IN THE DENTAL AND OCCLUSAL STABILITY
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dental and Occlusal Stability
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Essix retainer
    Intervention: Device: Essix retainer
  • 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.
    Intervention: Device: Hawley retainer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2012)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01583933
Other Study ID Numbers  ICMJE SFHA-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angela Maria Segura Cardona, CES University
Study Sponsor  ICMJE CES University
Collaborators  ICMJE Universidad de Antioquia
Investigators  ICMJE Not Provided
PRS Account CES University
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP