- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04018534
Effects Of Training On Brushing Behavior
July 11, 2019 updated by: Hakan Yilmaz, Okan University
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.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 22 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control group
The patients in control group received a standard printed educational material assisted with verbal information in accordance with British Orthodontics Society(BOS) educational goals.
|
This patients as control group received a standard printed educational material assisted with verbal information in accordance with British Orthodontics Society (BOS) educational goals.
|
|
Experimental: Video assisted education group
The patients in one of the study groups received a video assisted education
|
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.
|
|
Experimental: Hands-on training group
The patients in other study group received a hands-on training.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
PI was measured at the 8 weeks later in each patient.
|
|
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.
|
GI was measured at the 8 weeks later in each patient.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time duration spent for educational interventions
Time Frame: Average 30 minutes
|
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.
|
Average 30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2014
Primary Completion (Actual)
June 6, 2016
Study Completion (Actual)
November 24, 2018
Study Registration Dates
First Submitted
July 7, 2019
First Submitted That Met QC Criteria
July 11, 2019
First Posted (Actual)
July 12, 2019
Study Record Updates
Last Update Posted (Actual)
July 12, 2019
Last Update Submitted That Met QC Criteria
July 11, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 11022014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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