Orthodontic AppliancesNCT04018534
Effects Of Training On Brushing Behavior
A study testing Standard Verbal/Written Education, Video Assisted Education and Hands-on Training in people with Orthodontic Appliances and Oral Health Training, run by Okan University.
Trial summary
This study is a single-blind randomized controlled trial on fixed orthodontic appliance candidates (n = 90) assigned into a control group (n = 30) and two different study groups (n = 30 in each). Read more about this study
- Who is it for?
- Ages 12 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliances, Oral Health Training, Oral Hygiene
- What is being tested?
- Standard Verbal/Written Education, Video Assisted Education and Hands-on Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2014to 24 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Required non-extraction fixed orthodontic treatment, agree to use conventional stainless steel brackets (Gemini series; 3M Unitek, Monrovia, California, USA), at least 20 natural permanent teeth, crowding under 5 mm in the incisors and willing to participate in our research
Who cannot join
- Dental caries, periodontal disease, systemic or chronic diseases such as diabetes, physical or mental disorders, smoking, previous orthodontic treatment, extensive dental restorations, antibiotic use during the previous 3 months, dental fluorosis and use of powered tooth brushes.
About this study
Official title: Effectiveness of Three Different Types Educational Methods on Implementation of Proper Oral Hygiene Behaviour Prior to Orthodontic Treatment
This study is a single-blind randomized controlled trial on fixed orthodontic appliance candidates (n = 90) assigned into a control group (n = 30) and two different study groups (n = 30 in each). Patients who requiring non-extraction fixed orthodontic treatment, crowding under 5mm in the incisors and heaving at least 20 permanent teeth with healthy periodontal tissue and devoid of caries were included in the study. The control group received a standard printed educational material assisted with verbal information. The study groups either received video assisted or hands-on training about fixed orthodontic appliance and oral hygiene. The time requirements for all three educational interventions were recorded at the initial visit. The adequacy of oral hygiene is documented through plaque and gingival indices at the initial visit and 8th week of the treatment.
- Conditions
- Orthodontic Appliances, Oral Health Training, Oral Hygiene
- Being tested
- Standard Verbal/Written Education, Video Assisted Education, Hands-on Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Verbal/Written EducationBehavioural
This patients as control group received a standard printed educational material assisted with verbal information in accordance with British Orthodontics Society (BOS) educational goals.
Video Assisted EducationBehavioural
The video training consisted of two separate sessions, each one lasting 5 minutes, one about the treatment materials and the other about the oral hygiene successively and in compliance with the British Orthodontics Society (BOS) educational obligations. All of the candidates were allowed to rewind and watch the video presentation until they reach all of the educational goals. The accomplishment of the educational goals was documented through a written examination form filled in by the candidates themselves. All of the candidates have rated fullscore in the written examinations on both topics.
Hands-on TrainingBehavioural
The hands-on training consisting of two separate sessions was performed by one of the authors (E.A). The first is about the treatment materials and the second one is about the oral hygiene successively. They are in accordance with the British Orthodontics Society (BOS) educational obligations. All of the patients were allowed to ask questions freely until they reach all of the educational goals. The accomplishments of the educational goals were documented through a written examination form filled in by the candidates themselves. All of the candidates have rated fullscore in the written examinations on both topics. The time requirements for all three different educational interventions were recorded separately.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | The patients in control group received a standard printed educational material assisted with verbal information in accordance with British Orthodontics Society(BOS) educational goals. Receives: Behavioral: Standard Verbal/Written Education |
| Video assisted education group | Experimental | The patients in one of the study groups received a video assisted education Receives: Behavioral: Video Assisted Education |
| Hands-on training group | Experimental | The patients in other study group received a hands-on training. Receives: Behavioral: Hands-on Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index(PI) for oral health assessment.
The brushing habits of the patients were checked at each appointment and were recorded with PI. This measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth.
Measured: PI was measured at the 8 weeks later in each patient.
Gingival index(GI) for oral health assessment.
This index was used to assess the severity and prevalence of gingivitis.Probe was used as a sensor for GI scoring and the mesial, distal, buccal and lingual surfaces of the teeth were evaluated in patients undergoing fixed orthodontic treatment.
Measured: GI was measured at the 8 weeks later in each patient.
Secondary outcomes (1)
Time duration spent for educational interventions
The time requirements for all three different educational interventions were recorded separately.These time durations consisted of the education time needed for both fixed appliance components and oral hygiene educations all together.
Measured: Average 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start5 May 2014
- Primary completion6 Jun 2016
- Study completion24 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic AppliancesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 90 consecutive fixed orthodontic appliance treatment candidates in compliance with the above mentioned criteria were randomly assigned to 3 groups (n = 30 in each); Control group: The patients in control group received a standard printed educational material assisted with verbal information in accordance with BOS educational goals. Study group 1: The patients in one of the study groups received a video assisted education . Study group 2: The patients in other study group received a hands-on training.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fethiye Cakmak Ozlu, Erol Aktunc, Ersan Ilsay Karadeniz
- Responsible party
- Principal investigator, Hakan Yilmaz, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018534
- Sponsor's protocol ID
- 11022014
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozlu FC, Aktunc E, Yilmaz H, Karadeniz EI. Effectiveness of three different types of educational methods on implementation of proper oral hygiene behaviour prior to orthodontic treatment. Dental Press J Orthod. 2021 Mar 22;26(1):e2119248. doi: 10.1590/2177-6709.26.1.e2119248.oar. eCollection 2021.
PubMed 33759964
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Three Different Types Educational Methods on Implementation of Proper Oral Hygiene Behaviour Prior to Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT04018534
- Acronym / sponsor ID
- 11022014
- Conditions
- Orthodontic Appliances, Oral Health Training, Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Fethiye Cakmak Ozlu, Erol Aktunc, Ersan Ilsay Karadeniz
- Study start
- 5 May 2014 (actual)
- Primary completion
- 6 Jun 2016 (actual)
- Study completion
- 24 Nov 2018 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-blind randomized controlled trial on fixed orthodontic appliance candidates (n = 90) assigned into a control group (n = 30) and two different study groups (n = 30 in each). Patients who requiring non-extraction fixed orthodontic treatment, crowding under 5mm in the incisors and heaving at least 20 permanent teeth with healthy periodontal tissue and devoid of caries were included in the study. The control group received a standard printed educational material assisted with verbal information. The study groups either received video assisted or hands-on training about fixed orthodontic appliance and oral hygiene. The time requirements for all three educational interventions were recorded at the initial visit. The adequacy of oral hygiene is documented through plaque and gingival indices at the initial visit and 8th week of the treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 90 consecutive fixed orthodontic appliance treatment candidates in compliance with the above mentioned criteria were randomly assigned to 3 groups (n = 30 in each); Control group: The patients in control group received a standard printed educational material assisted with verbal information in accordance with BOS educational goals. Study group 1: The patients in one of the study groups received a video assisted education . Study group 2: The patients in other study group received a hands-on training.
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Behavioral: Standard Verbal/Written EducationThe patients in control group received a standard printed educational material assisted with verbal information in accordance with British Orthodontics Society(BOS) educational goals. |
| Video assisted education group | Experimental | Behavioral: Video Assisted EducationThe patients in one of the study groups received a video assisted education |
| Hands-on training group | Experimental | Behavioral: Hands-on TrainingThe patients in other study group received a hands-on training. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Required non-extraction fixed orthodontic treatment, agree to use conventional stainless steel brackets (Gemini series; 3M Unitek, Monrovia, California, USA), at least 20 natural permanent teeth, crowding under 5 mm in the incisors and willing to participate in our research
Key exclusion criteria (1 listed)
- Dental caries, periodontal disease, systemic or chronic diseases such as diabetes, physical or mental disorders, smoking, previous orthodontic treatment, extensive dental restorations, antibiotic use during the previous 3 months, dental fluorosis and use of powered tooth brushes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Verbal/Written EducationThis patients as control group received a standard printed educational material assisted with verbal information in accordance with British Orthodontics Society (BOS) educational goals. | Behavioural | Control group |
| Video Assisted EducationThe video training consisted of two separate sessions, each one lasting 5 minutes, one about the treatment materials and the other about the oral hygiene successively and in compliance with the British Orthodontics Society (BOS) educational obligations. All of the candidates were allowed to rewind and watch the video presentation until they reach all of the educational goals. The accomplishment of the educational goals was documented through a written examination form filled in by the candidates themselves. All of the candidates have rated fullscore in the written examinations on both topics. | Behavioural | Video assisted education group |
| Hands-on TrainingThe hands-on training consisting of two separate sessions was performed by one of the authors (E.A). The first is about the treatment materials and the second one is about the oral hygiene successively. They are in accordance with the British Orthodontics Society (BOS) educational obligations. All of the patients were allowed to ask questions freely until they reach all of the educational goals. The accomplishments of the educational goals were documented through a written examination form filled in by the candidates themselves. All of the candidates have rated fullscore in the written examinations on both topics. The time requirements for all three different educational interventions were recorded separately. | Behavioural | Hands-on training group |
Primary outcome
Plaque index(PI) for oral health assessment.
Time frame: PI was measured at the 8 weeks later in each patient.
The brushing habits of the patients were checked at each appointment and were recorded with PI. This measurement of the state of oral hygiene by Silness-Löe plaque index is based on recording both soft debris and mineralized deposits on the following teeth.
Gingival index(GI) for oral health assessment.
Time frame: GI was measured at the 8 weeks later in each patient.
This index was used to assess the severity and prevalence of gingivitis.Probe was used as a sensor for GI scoring and the mesial, distal, buccal and lingual surfaces of the teeth were evaluated in patients undergoing fixed orthodontic treatment.
1 secondary outcome
Time duration spent for educational interventions
Time frame: Average 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Derived from this study: PubMed 33759964Ozlu FC, Aktunc E, Yilmaz H, Karadeniz EI. Effectiveness of three different types of educational methods on implementation of proper oral hygiene behaviour prior to orthodontic treatment. Dental Press J Orthod. 2021 Mar 22;26(1):e2119248. doi: 10.1590/2177-6709.26.1.e2119248.oar. eCollection 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Orthodontic Appliances
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Active, not recruitingObservational study
Periodontal Health in Adults Treated With Fixed Orthodontic Appliances or Clear Aligners
Malocclusion, Periodontal Diseases
Active, not recruiting
Teleorthodontics Versus Conventional Follow-up During Early Interceptive Orthodontic Treatment in Children
Teledentistry, Orthodontics, Interceptive
Active, not recruiting
Effects of Green Tea Mouthwash on Halitosis, Periodontal Health, and Stress in Orthodontic Patients
Halitosis, Periodontal Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Verbal/Written Education, Video Assisted Education and Hands-on Training in people with Orthodontic Appliances and Oral Health Training, run by Okan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index(PI) for oral health assessment. (time frame: PI was measured at the 8 weeks later in each patient.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04018534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.