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OpenTrials
Completed

NCT Number: NCT02618330

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

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.

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Key information

Conditions

Retention

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

retainer

Device

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

Primary outcomes

  1. Survival times via recording to the patients' re-visit

    Time frame: one year

Secondary outcomes

  1. SF-36 scale for Quality of life

    Time frame: one month

  2. Comfort degrees assessed through Visual Analog Score

    Time frame: one month

  3. Retention effectiveness assessed according to 3D models

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Yafen Zhu

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
First posted
Dec 1, 2015
Registry last updated
Dec 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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