Essix Retainer vs Hawley Retainer (retainer)

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

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.

Study Overview

• Status: Unknown
• Conditions: Dental and Occlusal Stability
• Intervention / Treatment: Device: Essix retainer; Device: Hawley retainer

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: Interventional
• Enrollment (Anticipated): 46
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sandra Gómez, Orthodontist; Phone Number: 574 3127492; Email: sandraligomez11@gmail.com
• Study Contact Backup: Name: Angela María Segura Cardona, PhD in Epidemiology; Phone Number: 574 4440555; Email: asegura@ces.edu.co

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia
      • Recruiting
      • CES University
      • Contact: Angela Segura; Email: asegura@ces.edu.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 38 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CES University
• Collaborators: Universidad de Antioquia

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Anticipated): May 1, 2012

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Estimate): April 27, 2012
• Last Update Submitted That Met QC Criteria: April 26, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Dental stability; Occlusal stability; Retainers
• Other Study ID Numbers: SFHA-02