Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patient's Expectations, Preferences, Experiences Before, During and After the Treatment With Invisalign® Aligners

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04105491
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Nemec, Medical University of Vienna

Brief Summary:

Orthodontic treatment extends over a longer period of time. lt takes months or rather years and it is no short-term treatment. The current literature does not answer the question of patients' expectations on aligner treatment and patients' experiences during aligner therapy sufficiently. Therefore, it is clinically and ethically highly relevant to know answers to these questions. This knowledge can highly improve the orthodontic consultation and therapy as well as the patients' comfort and wellbeing during the therapy. The proposed questionnaire-based interview survey is anticipated as a two-vear study.

In the first year study patients' expectations and preferences before the aligner treatment with Invisalign® aligners will be evaluated as well as preliminary changes in quality of life during the first stages of the Invisalign® aligner treatment. In the second year study it is planned to continue with the time equivalent questionnaires of the first year study and to investigate the patients' expectations, patients' experiences and levels of quality of life during and after aligner treatment. Therefore, it is planned to enroll 55 patients in this multicentre questionnaire-based interview survey. Two different questionnaires will be handed out to the patients. The first questionnaire, the aligner questionnaire, collects information from three different time points regarding the patients' expectations, preferences, experiences and views on second opinion concerning the aligner treatment. The results of those three time points, i.e. first (Ta0 before treatment begin), second (Ta6Mo, after 6 months of treatment) and third (Ta final, after finishing the treatment) will be statistically described and compared over time.

We expect most questionnaires of the second (during aligner treatment) and third time points (after finishing of treatment) to be evaluated by the end of the second year (second-year study), as the average treatment duration is about two years. The aim of the second questionnaire (OHlP 14) is to find out the changes in quality of life and is scheduled be started already in the firsfyear study. This questionnaire will be handed out to the patients before the treatment begins (Tq0), at the first check-up after the beginning of the treatment (TqCo1) and semi-annually afterwards (Tq6Mo' Tq12Mo, Tq18Mo, Tq24Mo, Tq30Mo) and finally at the end of the treatment (Tq final).


Condition or disease Intervention/treatment
Surveys and Questionnaires Quality of Life Orthodontics Orthodontic Appliances Device: IInvisalign® Aligners

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Patient's Expectations, Preferences, Experiences Before, During and After the Treatment With Invisalign® Aligners
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : September 16, 2022
Estimated Study Completion Date : September 16, 2023

Group/Cohort Intervention/treatment
Aligner Patients
Patients who decided to be treated with Invisalign® aligners
Device: IInvisalign® Aligners
Clear aligner orthodontic treatment




Primary Outcome Measures :
  1. Patient expection on aligner therapy [ Time Frame: up to 6 months ]
    before treatment has started


Secondary Outcome Measures :
  1. Patient preferences and acceptences on aligner therapy [ Time Frame: up to 12 months ]
    during treatment

  2. Patient experiences on aligner therapy [ Time Frame: up tp 24 months ]
    after aligner therapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who decided to be treated with Invisalign® aligners
Criteria

Inclusion Criteria:

  • Invisalign® "full" aligner treatment
  • Invisalign® "lite" aligner treatment
  • Adult patients (18 years and older)

Exclusion Criteria:

  • Previous aligner treatment
  • Combined orthodontic and orthognathic surgical treatment
  • Combined bracket and aligner treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105491


Contacts
Layout table for location contacts
Contact: Michael Nemec, MD,DMD +43140070 ext 4321 michael.nemec@meduniwien.ac.at
Contact: Maria Strobl +43140070 ext 4301 maria.strobl@meduniwien.ac.at

Locations
Layout table for location information
Austria
University Dental Clinic Vienna Recruiting
Vienna, Austria, 1090
Contact: Michael Nemec, MD,DMD    +43 1 400704301    michael.nemec@meduniwien.ac.at   
Contact: Maria Strobl    +43 1 400704301    maria.strobl@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Publications:
Layout table for additonal information
Responsible Party: Michael Nemec, Dr. med. dent Dr. med. univ, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04105491    
Other Study ID Numbers: 1563/2019
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes