NCT01583933

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

4 months

First QC Date

April 23, 2012

Last Update Submit

April 26, 2012

Conditions

Dental and Occlusal Stability

Keywords

Dental stabilityOcclusal stabilityRetainers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Occlusal stability

    Up to 6 months

Study Arms (2)

Essix retainer

EXPERIMENTAL
Device: Essix retainer

Hawley retainer

ACTIVE COMPARATOR

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

Interventions

Essix retainerDEVICE

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.

Essix retainer
Hawley retainerDEVICE

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.

Hawley retainer

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CES University

Medellín, Antioquia, Colombia

RECRUITING

Central Study Contacts

Sandra Gómez, Orthodontist

CONTACT

574 3127492sandraligomez11@gmail.com

Angela María Segura Cardona, PhD in Epidemiology

CONTACT

574 4440555asegura@ces.edu.co

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 24, 2012

Study Start

September 1, 2011

Primary Completion

January 1, 2012

Study Completion

May 1, 2012

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

CO(1)