Bonding success rate of 2 different composites used for the bonding of attachments for the Invisalign® system
| ISRCTN | ISRCTN65557322 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65557322 |
- Submission date
- 02/08/2024
- Registration date
- 05/08/2024
- Last edited
- 05/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The goal of this prospective study is to compare the bonding success rate of 2 different composites used for the bonding of attachments for the Invisalign® system: the Transbond XT® from 3M Unitek® and the Tetric EvoCeram® from Ivoclar Vivadent®.
Who can participate?
Patients aged 12 - 75 years
What does the study involve?
Patients were assigned randomly between the experimental group with resin composite Tetric EvoCeram® (26 patients) or the control group with resin composite Transbond XT® (25 patients). Attachments were bonded with the given protocol and the number of failed bonding of attachments was registered at T1 (3 months). Patient age and sex influence on bonding failure was also analyzed. Student and 1-factor ANOVA tests were used when the variables were normal, and the non-parametric alternative of the Median Test when not distributed normally. The Chi-square test of independence was used to cross between two categorical variables.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Universidad Alfonso X el Sabio (Spain)
When is the study starting and how long is it expected to run for?
September 2021 to August 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
inietsan@yahoo.com
hpatu@myuax.com
Contact information
Public, Scientific, Principal Investigator
C. de Albarracín, 35, San Blas-Canillejas
Madrid
28037
Spain
 ORCID ID |
0009-0007-3840-2960 |
|---|---|
| Phone | +34 63857181 |
| hpatu@myuax.com |
Study information
| Study design | Single-center prospective randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Dental clinic, Medical and other records, University/medical school/dental school |
| Study type | Treatment, Efficacy |
| Participant information sheet | 45880_PIS.pdf |
| Scientific title | Bonding success rate of 2 different composites used for the bonding of attachments for the Invisalign® system |
| Study objectives | There is no difference in attachment loss in the first 3 months of orthodontic treatment between Transbond XT® and Tetric Evo Ceram® |
| Ethics approval(s) |
Approved 07/04/2022, University Alfonso X el Sabio (Avenida de la Universidad s/n., Villanueva de la Cañada, 28691, Spain; +34 918105000; comitedebioetica@uax.es), ref: 2022_3/139 |
| Health condition(s) or problem(s) studied | Malocclusion |
| Intervention | Two composite materials (Transbond and Tetric Ceram) for attachments for orthodontic aligner treatments were used. Once bonded, the attachment loss was registered in the first 3 months. The patients were randomly assigned to only one of the two groups using the software “Research Randomizer” available online at the following link: https://www.randomizer.org/. All attachments in the same patients were from the same material, bonding was performed using fabricant recommendations. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The number of debonded attachments on each patient (2 groups: Transbond and Tetric Evo Ceram) measured using a visual inspection at T0 at the appointment when the attachments were bonded, and monthly for 3 months |
| Secondary outcome measures | Differences in the failure rate (debonded attachments) regarding sex and age of the patient using data recorded in patient records at T0 at the appointment when the attachments were bonded, and monthly for 3 months |
| Overall study start date | 01/09/2021 |
| Completion date | 30/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Lower age limit | 12 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 51 |
| Total final enrolment | 51 |
| Key inclusion criteria | 1. Patients in permanent dentition between 12 and 75 years old 2. Men and women 3. Collaborator and with informed consent confirmed |
| Key exclusion criteria | 1. Patients in mixed dentition 2. Syndromic 3. Undergoing orthognathic surgery 4. Teeth with porcelain crown or composite restauration. |
| Date of first enrolment | 01/11/2022 |
| Date of final enrolment | 30/05/2023 |
Locations
Countries of recruitment
- Spain
Study participating centre
Madrid
28037
Spain
Sponsor information
University/education
Albarracín 35
Madrid
28037
Spain
| Phone | +34 914402330 |
|---|---|
| pmartnpa@externos.uax.es | |
| Website | https://www.uax.com |
"ROR" |
https://ror.org/054ewwr15 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 05/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the main researcher Hugo Patural: hugopatural@icloud.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 05/08/2024 | No | Yes |
Additional files
Editorial Notes
05/08/2024: Study's existence confirmed by University Alfonso X el Sabio.
