- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06162923
The Effectiveness of Reinforcement of Oral Hygiene Education Through Video During Fixed Orthodontic Treatment in Adults
The Effectiveness of Reinforcement of Oral Hygiene Education Through Video During Fixed Orthodontic Treatment in Adults -A Randomised Clinical Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Orthodontic treatment is a technique for straightening teeth or correcting malocclusions that has many recognised benefits, including improved aesthetics and patient self-esteem. Rapid advances in orthodontic treatment have broadened the area of treatment to include not just children and adolescents, but even adults. Adult patients seeking orthodontic treatment have increased in number over the past few years, for a variety of reasons, the most prevalent of which is the desire to straighten their teeth and improve their smile.
The key to successful orthodontic treatment is correcting occlusion in the best feasible way to improve aesthetics and function while preserving the pre-existing health of teeth and supporting tissues. Fixed appliances increase the retention areas for plaque accumulation, and this often makes maintaining optimal self-performed oral hygiene a challenge for the patients. Dental plaque that builds upon the orthodontic brackets in a poor oral environment consists of pathogenic biofilms that can lead to undesirable complications such as white spot lesions, gingivitis, and periodontal breakdown. Moreover, poor oral hygiene during orthodontic treatment often results in poor treatment quality and prolonged treatment duration. Poor oral hygiene is estimated to be the reason for 5%-10% of orthodontic patients failing to complete treatment.
Successful orthodontic treatment requires the patient's cooperation, in particular the maintenance of oral hygiene, which is controlled by the patient throughout the orthodontic treatment. Studies have indicated that minimal periodontal disease, bone loss, and cavities will occur throughout the course of fixed orthodontic treatment provided proper plaque control measures are implemented. In order to achieve optimal oral hygiene, professionals must provide detailed and understandable instructions, as well as suitable equipment and patient motivation, which is crucial for ensuring compliance. However, adequate plaque control still necessitates that each individual engages in regular oral hygiene behaviours. It is difficult to ensure patient compliance with home care recommendations, and as a result, long-term treatments such as orthodontic frequently have only a 50% compliance rate.
In dentistry, education is utilised to increase patient knowledge growth since it has the greatest influence on behavioural change, particularly with regard to oral hygiene. It has been demonstrated that repetition and reinforcement play an important role in the sustainability of health behaviour. Previous studies of oral health education have found that oral health educational programmes can only provide short-term improvements in oral health behaviour and oral health status, and this is especially true for most of the single session programs. Furthermore, Cozzani, in his study, found that post-procedural communication between the orthodontist and patient is an important element in improving dental hygiene compliance. By fostering mutual trust, the orthodontist may ensure that oral hygiene instructions are followed more consistently and educate patients about the benefits of behaving properly. Therefore, oral health education should be a continuous effort, and repetition and reinforcement are crucial to the long-term success of oral health educational programmes. As fixed orthodontic treatment can take more than two years to complete and requires patient compliance with perfect oral hygiene throughout the treatment, repetition and reinforcement of oral hygiene education play a significant role in the sustainability of good oral hygiene behaviour.
In dentistry, many studies have been conducted to assess the effectiveness of various oral health educational strategies in encouraging behavioural changes in patients undergoing fixed appliance orthodontic treatment. A variety of techniques, including verbal communication, written material with pictures, videos, and visual demonstration using models or experimental tools like indicator dyes or displaying live bacteria to patients under a phase contrast microscope, have been used. Although the one-to-one approach to oral health education is promising in terms of improving oral hygiene, it is time-consuming and impractical. With technological advancements and increased internet availability, the use of videos as electronic health education material is gaining acceptability and becoming an appealing medium for communicating information to patients. Video-based oral hygiene education can be presented in a variety of methods, such as chairside, where patients are required to watch the video in the clinic, or it can be provided to the patient to watch at home.
To the best of the investigators knowledge, no study has been done to assess the influence of different methods of video-assisted oral hygiene reinforcement in improving patients' oral hygiene throughout fixed orthodontic treatment and minimal studies on the impacts of oral hygiene reinforcement have been undertaken purely on adult patients. Based on the available data, the majority of the studies did not look into the outcomes for the patients' oral health in more detail after discontinuing the oral hygiene reinforcement. Therefore, the impacts of oral hygiene reinforcement via different video delivery methods will give crucial data and insight into the oral health outcomes of adult patients receiving fixed orthodontic treatment, and we would also like to study the effects when the oral hygiene reinforcement is discontinued.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Phey Ling Lee
- Phone Number: +60176988250
- Email: phey_ling@hotamil.com
Study Locations
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-
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Kuala Lumpur, Malaysia, 50603
- Recruiting
- Faculty of Dentistry, Universiti Malaya
-
Contact:
- Phey Ling Lee
- Phone Number: +60176988250
- Email: phey_ling@hotmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 years old
- Require fixed orthodontic treatment in upper and lower arches
- Agree to use conventional stainless-steel brackets
- Full-Mouth Plaque Score of 40-70%
- Absence of caries and overhanging or distorted restoration
- Stable or no periodontal diseases with the presence of Basic Periodontal Examination (BPE) code 0/1/2 with no obvious evidence of interdental recession
- Have at least 20 teeth (Ozlu et al., 2021)
- Capable of using and accessing technology gadgets such as a smartphone, tablet, laptop, and computer
- Having access to the internet and having WhatsApp's account
Exclusion Criteria:
- Presence of BPE code 3/4
- Presence of current active periodontal disease
- Smokers
- Severe or chronic illnesses (such as diabetes, cardiovascular diseases, stroke, etc)
- Physically impaired and syndromic patient
- Orofacial deformities
- History of previous orthodontic treatment
- Intake of antibiotics within 6 months before and during the study period
- Taking drugs that influence gingival inflammation or bleeding (eg anticoagulants, cortisone)
- Pregnant or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
|
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Experimental: On-site video group
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Each participant will receive standard oral hygiene reinforcement verbally, followed by watching a pre-recorded oral hygiene instruction video on a tablet
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Experimental: Remote video group
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After receiving normal oral hygiene reinforcement verbally, each participant will be sent a video link Whatapps instant message, which they are required to watch at home
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Orthodontic Plaque Index (OPI)
Time Frame: Every two months for up to 12 months
|
The plaque deposits around the brackets will be disclosed using a disclosing solution to facilitate their detection.
The dentition is divided into six sextants.
The amount of plaque accumulation on each tooth surface at the bracket base (mesial, distal, occlusal/incisal, and cervical) is represented by a score ranging from 0 to 4. 0 represents best outcome whereas 4 represents worst outcome.
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Every two months for up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Full-Mouth Bleeding Score (FMBS)
Time Frame: Every two months for up to 12 months
|
Presence or absence of gingival bleeding on each tooth surface (mesial, distal, buccal and lingual/palatal) in the dentition is recorded in a dichotomous manner.
The FMBS will be performed through gentle probing of the gingival crevice on each tooth surface.
A positive finding will be recorded if bleeding occurs within 10 seconds.
Yes represents the presence of bleeding (worse outcome) and no represents the absence of bleeding (better outcome)
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Every two months for up to 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- DrOrtho LPL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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