Essix Retainer vs Hawley Retainer

Dental and Occlusal Stability Clinical Trial

— retainer  

Official title:

PHASE 3 STUDY OF THE EFFECTIVITY OF TWO RETAINERS IN THE DENTAL AND OCCLUSAL STABILITY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01583933
• Other study ID #: SFHA-02
• Status: Recruiting
• Phase: Phase 3
• First received: April 23, 2012
• Last updated: April 26, 2012
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: April 2012
• Source: CES University
• Contact: Sandra Gómez, Orthodontist
• Phone: 574 3127492
• Email: sandraligomez11[@]gmail.com
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: May 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental and Occlusal Stability

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	CES University	Medellín	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
CES University	Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dental stability	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.	Up to 6 months	No
Secondary	Occlusal stability	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.	Up to 6 months	No