Condition category
Oral Health
Date applied
04/10/2020
Date assigned
07/10/2020
Last edited
07/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Selma Elekdag-Turk

ORCID ID

https://orcid.org/0000-0002-2799-6501

Contact details

Ondokuz Mayıs University
Faculty of Dentistry
Department of Orthodontics
Samsun
55200
Turkey
+90 (0)5446403424
s.elekdag@omu.edu.tr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

OMÜ KAEK 2018/416

Study information

Scientific title

Evaluation of the flash-free adhesive system for a 6-month period: a split-mouth trial

Acronym

Study hypothesis

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

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

Study design

Single-center randomized study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

08/06/2018

Overall trial end date

18/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

30

Total final enrolment

30

Participant 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

Recruitment start date

17/09/2018

Recruitment end date

18/12/2018

Locations

Countries of recruitment

Turkey

Trial participating centre

Ondokuz Mayıs University
Faculty of Dentistry Department of Orthodontics
Samsun
55210
Turkey

Sponsor information

Organisation

Ondokuz Mayıs University

Sponsor details

Körfez
19 Mayıs Ünv.
Samsun
55200
Turkey
+90 (0)3623121919
samsunkaek@omu.edu.tr

Sponsor type

University/education

Website

https://samsunkaek.omu.edu.tr/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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).

Intention to publish date

01/11/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/10/2020: Trial's existence confirmed by Ondokuz Mayıs University.