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
|Condition or disease||Intervention/treatment||Phase|
|Dental and Occlusal Stability||Device: Essix retainer Device: Hawley retainer||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PHASE 3 STUDY OF THE EFFECTIVITY OF TWO RETAINERS IN THE DENTAL AND OCCLUSAL STABILITY|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||May 2012|
|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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01583933
|Contact: Sandra Gómez, Orthodontist||574 firstname.lastname@example.org|
|Contact: Angela María Segura Cardona, PhD in Epidemiology||574 email@example.com|
|Medellín, Antioquia, Colombia|
|Contact: Angela Segura firstname.lastname@example.org|