Condition category
Oral Health
Date applied
03/09/2014
Date assigned
16/10/2014
Last edited
16/10/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Wire dental braces (fixed vestibular multi-bracket appliances) are traditionally considered to be the best treatment (gold standard) for correcting misaligned teeth (dental malocclusion) in teenage patients. However, patients wearing wire braces are 5 times more likely to develop dental cavities (caries) and white spot lesions (often an early sign of tooth decay) than people who don’t. Such damage to the teeth cannot be reversed. Invisalign is an alternative to the wire brace. It is made out of plastic, using transparent aligners to gradually adjust the affected teeth. It is often used by people who have misaligned teeth but want a more attractive solution to wearing the traditional brace. Here, we want to find out whether wearing Invisalign rather than wire dental braces will result in fewer or more white spot lesions after 6 months and then after 12 months of therapy.

Who can participate?
Patients aged between 13-19 years needing dental (orthodontic) treatment to correct misaligned teeth.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are treated with a traditional multi-bracket appliance for orthodontic treatment. Those in group 2 receive Invisalign therapy. All participants are examined for white spot lesions at the start of the study, after 6 months of orthodontic treatment, and then after 12 months of treatment.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Department of Orthodontics, University Hospital Freiburg (Germany)

When is the study starting and how long is it expected to run for?
November 2014 to October 2016

Who is funding the study?
International Align Research Award of the Align Technology, North America (USA)

Who is the main contact?
Professor Britta A. Jung

Trial website

Contact information

Type

Scientific

Primary contact

Prof Britta A. Jung

ORCID ID

Contact details

Head of the Department of Orthodontics
Department of Orthodontics
University Hospital Freiburg
Germany
Hugstetter Str. 55
Freiburg
Germany
79106
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Invisalign - a concept for the prevention of white spot lesions in teenaged orthodontic patients? A prospective controlled clinical trial

Acronym

Study hypothesis

The aim of this study is to investigate the incidence of white spot lesions during orthodontic treatment with Invisalign and multi-bracket appliance treatment (the gold standard) in teenaged patients.
The null hypothesis of no difference in the incidence of white spot lesions between teeth undergoing treatment with fixed braces and Invisalign therapy will be investigated. The investigation will be designed as a prospective, bicenter controlled clinical study.

Ethics approval

Ethics Committee of Albert-Ludwigs-University of Freiburg, Germany (Ref. No: 406/14 (MPG§23))

Study design

A prospective controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malocclusion

Intervention

Two groups of patients (male and female, aged 13-19 years) will be randomly allocated into one of two arms:
1. Group 1 will consist of 30 patients. All of these patients receive a traditional multi-bracket appliance for orthodontic treatment.
2. Group 2 will consist of 30 patients. All of these patients receive Invisalign therapy for orthodontic treatment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Macroscopic characterization (presence, frequency, and severity) of white spot lesions at baseline, after 6 months, and after 12 months of orthodontic treatment. The severity of disease will be rated according to Gorelick's classification:
Grade 0: no visible white spot lesions on clinical investigation
Grade 1: minor white spot lesions
Grade 2: severe white spot lesions
Grade 3: white spot lesions with cavitation
2. Determination of fluorescence, size and lesion depth and the bacterial acitivity of white spot lesions by means of quantitative light-induced fluorescence measurement (QLF) at baseline, after 6 months, and after 12 months of orthodontic treatment.

Secondary outcome measures

Determination of fluorescence, size and lesion depth and the bacterial activity of white spot lesions by means of quantitative light-induced fluorescence measurement (QLF) after active orthodontic treatment and 6 month later.

Overall trial start date

01/11/2014

Overall trial end date

01/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Orthodontic indication for a vestibular multi-bracket appliance or
2. The need and desire to receive Invisalign therapy
3. Persons aged 13-19 years (teenagers) with fully erupted and visible teeth before treatment
4. No white spot lesions at baseline/no caries
5. Good oral hygiene
6. Written informed consent

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patients with cheilognathopalatoschisis or other syndromes associated with craniofacial abnormalities
2. Patients with enamel abnormalities

Recruitment start date

01/11/2014

Recruitment end date

01/10/2016

Locations

Countries of recruitment

Germany

Trial participating centre

Head of the Department of Orthodontics
Freiburg, Germany
79106
Germany

Sponsor information

Organisation

Align Technology, Inc. (USA)

Sponsor details

2560 Orchard Parkway
San Jose CA 95131
San Jose
95131
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

International Align Research Award of the Align Technology, North America (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes