NCT02618330

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

November 1, 2015

Enrollment Period

1.9 years

First QC Date

November 25, 2015

Last Update Submit

November 30, 2015

Conditions

Retention

Outcome Measures

Primary Outcomes (1)

  • Survival times via recording to the patients' re-visit

    one year

Secondary Outcomes (3)

  • SF-36 scale for Quality of life

    one month

  • Comfort degrees assessed through Visual Analog Score

    one month

  • Retention effectiveness assessed according to 3D models

    one year

Study Arms (2)

retainer: 0.75-mm-thick film

EXPERIMENTAL
Device: retainer

retainer: 1.00-mm-thick film

EXPERIMENTAL
Device: retainer

Interventions

retainerDEVICE

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

retainer: 0.75-mm-thick filmretainer: 1.00-mm-thick film

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 28257727DERIVED

MeSH Terms

Interventions

Orthodontic Retainers

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PHD candidate

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 1, 2015

Study Start

July 1, 2013

Primary Completion

June 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-11