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

• Sponsor: Yafen Zhu (Other)
• Overall Status: Completed
• CT.gov ID: NCT02618330
• Collaborator: (none)
• Enrollment: 80
• Arms: 2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Retention	Device: retainer	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Survival times via recording to the patients' re-visit [one year]

Secondary Outcome Measures

1. SF-36 scale for Quality of life [one month]

2. Comfort degrees assessed through Visual Analog Score [one month]

3. Retention effectiveness assessed according to 3D models [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Yafen Zhu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yafen Zhu, PHD candidate, Sichuan University
• ClinicalTrials.gov Identifier: NCT02618330
• Other Study ID Numbers: WCHSIRB-ST-2013-094
• First Posted: Dec 1, 2015
• Last Update Posted: Dec 3, 2015
• Last Verified: Nov 1, 2015

Study Results

No Results Posted as of Dec 3, 2015