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

NCT04105491 | Unknown FDA Device

• 1 other identifier: 1563/2019
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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).

Conditions

Surveys and Questionnaires; Quality of Life; Orthodontics; Orthodontic Appliances

Outcome Measures

Primary Outcomes (1)

• Patient expection on aligner therapy

  before treatment has started

  up to 6 months

Secondary Outcomes (2)

• Patient preferences and acceptences on aligner therapy

  up to 12 months

• Patient experiences on aligner therapy

  up tp 24 months

Study Arms (1)

Aligner Patients

Patients who decided to be treated with Invisalign® aligners

Device: IInvisalign® Aligners

Interventions

IInvisalign® Aligners DEVICE

Clear aligner orthodontic treatment

Aligner Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who decided to be treated with Invisalign® aligners

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

University Dental Clinic Vienna

Vienna, 1090, Austria

RECRUITING

Related Publications (6)

• Flores-Mir C, Brandelli J, Pacheco-Pereira C. Patient satisfaction and quality of life status after 2 treatment modalities: Invisalign and conventional fixed appliances. Am J Orthod Dentofacial Orthop. 2018 Nov;154(5):639-644. doi: 10.1016/j.ajodo.2018.01.013.

  PMID: 30384934 BACKGROUND

• Pacheco-Pereira C, Brandelli J, Flores-Mir C. Patient satisfaction and quality of life changes after Invisalign treatment. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):834-841. doi: 10.1016/j.ajodo.2017.10.023.

  PMID: 29853241 BACKGROUND

• Azaripour A, Weusmann J, Mahmoodi B, Peppas D, Gerhold-Ay A, Van Noorden CJ, Willershausen B. Braces versus Invisalign(R): gingival parameters and patients' satisfaction during treatment: a cross-sectional study. BMC Oral Health. 2015 Jun 24;15:69. doi: 10.1186/s12903-015-0060-4.

  PMID: 26104387 BACKGROUND

• Liu Z, McGrath C, Hagg U. Changes in oral health-related quality of life during fixed orthodontic appliance therapy: an 18-month prospective longitudinal study. Am J Orthod Dentofacial Orthop. 2011 Feb;139(2):214-9. doi: 10.1016/j.ajodo.2009.08.029.

  PMID: 21300250 BACKGROUND

• Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.

  PMID: 8193981 BACKGROUND

• Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

  PMID: 9332805 BACKGROUND

Central Study Contacts

Michael Nemec, MD,DMD

CONTACT

+43140070; michael.nemec@meduniwien.ac.at

Maria Strobl

CONTACT

+43140070; maria.strobl@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. dent Dr. med. univ

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 26, 2019
• Study Start: September 16, 2019
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)