Invisalign - a concept for the prevention of white spot lesions in teenaged orthodontic patients?
| ISRCTN | ISRCTN33826201 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33826201 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/09/2014
- Registration date
- 16/10/2014
- Last edited
- 16/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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 dont. 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
Contact information
Scientific
Head of the Department of Orthodontics
Department of Orthodontics
University Hospital Freiburg, Germany
Hugstetter Str. 55
Freiburg, Germany
79106
Germany
Study information
| Study design | A prospective controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Invisalign - a concept for the prevention of white spot lesions in teenaged orthodontic patients? A prospective controlled clinical trial |
| Study objectives | 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(s) | Ethics Committee of Albert-Ludwigs-University of Freiburg, Germany (Ref. No: 406/14 (MPG§23)) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2014 |
| Completion date | 01/10/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key exclusion criteria | 1. Patients with cheilognathopalatoschisis or other syndromes associated with craniofacial abnormalities 2. Patients with enamel abnormalities |
| Date of first enrolment | 01/11/2014 |
| Date of final enrolment | 01/10/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
79106
Germany
Sponsor information
Industry
2560 Orchard Parkway, San Jose CA 95131
San Jose
95131
United States of America
"ROR" |
https://ror.org/005sbaa41 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
