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

NCT ID: NCT02618330

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Retention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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retainer: 0.75-mm-thick film

Group Type EXPERIMENTAL

retainer

Intervention Type DEVICE

24 h wearing whether 0.75-mm-thick or 1.00-mm-thick film retainer

retainer: 1.00-mm-thick film

Group Type EXPERIMENTAL

retainer

Intervention Type DEVICE

24 h wearing whether 0.75-mm-thick or 1.00-mm-thick film retainer

Interventions

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retainer

24 h wearing whether 0.75-mm-thick or 1.00-mm-thick film retainer

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yafen Zhu

OTHER

Sponsor Role lead

Responsible Party

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Yafen Zhu

PHD candidate

Responsibility Role SPONSOR_INVESTIGATOR

References

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Zhu Y, Lin J, Long H, Ye N, Huang R, Yang X, Jian F, Lai W. Comparison of survival time and comfort between 2 clear overlay retainers with different thicknesses: A pilot randomized controlled trial. Am J Orthod Dentofacial Orthop. 2017 Mar;151(3):433-439. doi: 10.1016/j.ajodo.2016.10.019.

Reference Type DERIVED
PMID: 28257727 (View on PubMed)

Other Identifiers

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WCHSIRB-ST-2013-094

Identifier Type: -

Identifier Source: org_study_id