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

Retention Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618330
• Other study ID #: WCHSIRB-ST-2013-094
• Status: Completed
• Phase: N/A
• First received: November 25, 2015
• Last updated: November 30, 2015
• Start date: July 2013

Study information

• Verified date: November 2015
• Source: Sichuan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Retention

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yafen Zhu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival times via recording to the patients' re-visit		one year	No
Secondary	SF-36 scale for Quality of life		one month	No
Secondary	Comfort degrees assessed through Visual Analog Score		one month	No
Secondary	Retention effectiveness assessed according to 3D models		one year	No