The Clinical Evaluation of Two Different Film Thicknesses of Clear Overlay Retainer.

November 30, 2015 updated by: Yafen Zhu
The aims of this study were to compare health related quality of life, comforts degrees，retention effectiveness, and failure rates as well as survival times between two clear overlay retainers with different thicknesses, thus to provide basis information regarding appropriate selections of the thickness of clear overlay retainers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients after active orthodontic treatment;
  • Must be healthy without systemic and oral diseases;
  • The central incisors, canines and first molars of both upper and lower arches must be existed;
  • Agreed to the trial and signed informed consent forms, either by themselves, or their parents.

Exclusion Criteria:

  • Oral habits such as bruxism and clenching,
  • Do not accept this type of retainers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: retainer: 0.75-mm-thick film
Device: retainer
24 h wearing whether 0.75-mm-thick or 1.00-mm-thick film retainer
Experimental: retainer: 1.00-mm-thick film
Device: retainer
24 h wearing whether 0.75-mm-thick or 1.00-mm-thick film retainer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival times via recording to the patients' re-visit
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
SF-36 scale for Quality of life
Time Frame: one month
one month
Comfort degrees assessed through Visual Analog Score
Time Frame: one month
one month
Retention effectiveness assessed according to 3D models
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yafen Zhu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 25, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • WCHSIRB-ST-2013-094

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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