ClinicalTrials.gg
Status unknownNCT01583933retainerUpdated Apr 27, 2012

Essix Retainer vs Hawley Retainer

A Phase 3 interventional study of Essix retainer and Hawley retainer in Dental and Occlusal Stability, sponsored by CES University. Status unknown at 1 site in Colombia. Open to participants aged 16 Years to 40 Years. Per ClinicalTrials.gov, last updated 2012-04-27.

Sponsored by CES University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
16 Years to 40 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Dental and Occlusal Stability

Keywords

  • Dental stability
  • Occlusal stability
  • Retainers
03

In context

Lead sponsor

CES University is the lead sponsor of 29 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Essix retainer

    Device: Essix retainer

  • 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

Interventions

  • DeviceEssix 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.

  • DeviceHawley 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.

06

What researchers measure

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.

    Time frame: Up to 6 months

Secondary outcomes

  1. 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.

    Time frame: Up to 6 months

07

Study locations

1 of 1 sites recruiting
  • CES University
    Medellín, Antioquia, Colombia
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2011, a primary completion of Jan 2012 and a completion of May 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2012
First posted
Apr 24, 2012
Start
Sep 2011
Primary completionActual
Jan 2012
CompletionEst.
May 2012
Last update
Apr 27, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01583933
Lead sponsor
CES University
Collaborators
Universidad de Antioquia
Responsible party
Angela Maria Segura Cardona (Research, CES University) — Principal investigator
First posted
Apr 24, 2012
Start date
Sep 2011
Primary completion
Jan 2012
Completion
May 2012 (estimated)
Last update
Apr 27, 2012

Study contacts

Sandra Gómez, Orthodontist
Contact
sandraligomez11@gmail.com
574 3127492
Angela María Segura Cardona, PhD in Epidemiology
Contact
asegura@ces.edu.co
574 4440555

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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