Essix Retainer vs Hawley Retainer (retainer)
|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.
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|