Evaluation of a new adhesive system for orthodontic braces for a 6-month period
| ISRCTN | ISRCTN26731749 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26731749 |
| Secondary identifying numbers | OMÜ KAEK 2018/416 |
- Submission date
- 04/10/2020
- Registration date
- 07/10/2020
- Last edited
- 23/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Bracket failure (bracket detachment from the tooth) hinders the smooth progress of orthodontic treatment. Thus, a bracket failure rate that is as low as possible is of utmost importance for the clinician as well as for the patient. Recently, a new adhesive system was introduced. This system reduces the steps during bracket placement. Thus, the aim of this study is to evaluate the clinical performance (i.e. bracket failure as well as chair time) of this newly introduced adhesive pre-coated bracket system (PS) compared with a conventional bracket system (CS).
Who can participate?
Patients undergoing orthodontic treatment without tooth extraction
What does the study involve?
Participants receive orthodontic treatment where the mouth is divided into four segments that are randomly assigned to either the PS or CS bracket system. Bracket failure is measured over 6 months.
What are the possible benefits and risks of participating?
The risks of this study are the same as the risks of any routine non-extraction orthodontic treatment. No extra risks are present. The study will give insight concerning the chair time, i.e. the amount of time a patient spends in the chair for treatment, of these systems. Chair time is of great importance, particularly during the COVID-19 pandemic. Furthermore, this study will provide data on whether or not this system (PS) is as reliable as CS.
Where is the study run from?
Ondokuz Mayıs University (Turkey)
When is the study starting and how long is it expected to run for?
June 2018 to June 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Selma Elekdag-Türk
s.elekdag@omu.edu.tr
Contact information
Scientific
Ondokuz Mayıs University
Faculty of Dentistry
Department of Orthodontics
Samsun
55200
Türkiye
 ORCID ID |
0000-0002-2799-6501 |
|---|---|
| Phone | +90 (0)5446403424 |
| s.elekdag@omu.edu.tr |
Study information
| Study design | Single-center randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evaluation of the flash-free adhesive system for a 6-month period: a split-mouth trial |
| Study objectives | The aim of this study was the evaluation of the following parameters: 1. The comparison of the bond failure and survival rates of the APC FF Adhesive Coated Appliance System (3M Unitek) with an OC system (Transbond XT Light Cure Adhesive Paste; 3M Unitek) for a 6-month period. 2. Comparison of the bond failure and survival rates of the upper and lower arches. 3. Comparison of the bond failure and survival rates for incisor, canine and premolar teeth. 4. Comparison of bracket failure and survival rates with respect to gender. 5. Comparison of the ARI scores upon bracket failure. 6. Comparison of the chair time required for each bonding procedure. The null hypothesis was that there would be no difference in the aforementioned parameters. |
| Ethics approval(s) | Approved 13/09/2018, Research Ethics Committee at the University of Ondokuz Mayıs (Former Dental School Building, Ondokuz Mayıs University, 55200 Atakum/Samsun, Turkey; +90 (0)362 312 19 19/2782; omutaek@gmail.com), ref: OMÜ KAEK 2018/416 |
| Health condition(s) or problem(s) studied | Orthodontic malocclusion |
| Intervention | Patients willing to participate in this study receive orthodontic treatment with a split-mouth design, i.e. the mouth is divided into four experimental segments that are randomly assigned to either the pre-coated bracket system (PS) or a conventional bracket system (CS). The observation period for his study is 6 months. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Adhesive pre-coated bracket system, operator-coated conventional bracket system |
| Primary outcome measure | Bracket failure, i.e. bracket detachment from the tooth, is visually observed. Bracket failure can occur at any timepoint during the observation period. Bracket failure was recorded at the routine monthly controls of the patients. |
| Secondary outcome measures | Type of failure: the bracket may have detached from the tooth intact with adhesive or without adhesive. Furthermore, the bracket may have fractured. These types of failures can occur at any timepoint during the observation period. These types of failures were recorded at the routine monthly controls of the patients. |
| Overall study start date | 08/06/2018 |
| Completion date | 18/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Willingness to participate in this research project 2. Fully erupted maxillary and mandibular teeth with intact buccal enamel 3. Angle Class I and mild Class II malocclusions 4. Non-extraction patients 5. Normal overbite (1-2 mm) 6. Absence of severe rotations. Severe rotations would have prevented bracket placement or correct bracket placement at the first appointment 7. Absence of pretreatment of teeth with any chemical agents 8. Good oral hygiene, i.e. no bleeding upon probing |
| Key exclusion criteria | 1. Patients with skeletal problems 2. Patients with missing teeth 3. Patients with systemic disease 4. Patients with a previous history of orthodontic treatment |
| Date of first enrolment | 17/09/2018 |
| Date of final enrolment | 18/12/2018 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Department of Orthodontics
Samsun
55210
Türkiye
Sponsor information
University/education
Körfez, 19 Mayıs Ünv.
Samsun
55200
Türkiye
| Phone | +90 (0)3623121919 |
|---|---|
| samsunkaek@omu.edu.tr | |
| Website | https://samsunkaek.omu.edu.tr/ |
"ROR" |
https://ror.org/028k5qw24 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/11/2020 |
|---|---|
| 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. All additional documents are available upon request from Dr Selma Elekdağ-Türk. Furthermore, the study protocol and statistical analyses will be available upon the publication of this manuscript. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Dr Tamer Türk (turkset@superonline.com, tamert@omu.edu.tr) and Prof. Dr Selma Elekdag-Türk (elekdagturk@yahoo.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/06/2023 | 23/06/2023 | Yes | No |
Editorial Notes
23/06/2023: Publication reference added.
07/10/2020: Trial's existence confirmed by Ondokuz Mayıs University.
