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Oral Hygiene Reinforcement During Fixed Orthodontic TreatmentNCT06162923

The Effectiveness of Reinforcement of Oral Hygiene Education Through Video During Fixed Orthodontic Treatment in Adults

A study testing On-site video group and Remote video group in people with Oral Hygiene Reinforcement During Fixed Orthodontic Treatment, run by University of Malaya at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Effective oral hygiene education is paramount to ensure lasting good oral hygiene habits in patients receiving fixed orthodontic treatment. Repetition and reinforcement play an important role in the sustainability of oral health behaviour. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
On-site video group and Remote video group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteMalaysia
Study dates
1 Apr 2023to Nov 2024
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site, 1 recruiting
  • Faculty of Dentistry, Universiti Malaya

    Kuala Lumpur, 50603

    Phey Ling Lee, +60176988250, phey_ling@hotmail.com

    Recruiting

Other trials in Malaysia

About this study

Official title: The Effectiveness of Reinforcement of Oral Hygiene Education Through Video During Fixed Orthodontic Treatment in Adults -A Randomised Clinical Trial

Effective oral hygiene education is paramount to ensure lasting good oral hygiene habits in patients receiving fixed orthodontic treatment. Repetition and reinforcement play an important role in the sustainability of oral health behaviour. Video-based oral hygiene education can be provided in chairside, or it can be provided to the participant to watch at home, saving clinicians a lot of time. The study aims to investigate the long-term effects of different methods of video-assisted oral hygiene reinforcement on the oral hygiene of participants receiving fixed orthodontic treatment, as well as the consequences when reinforcement is discontinued. Sixty participants will be randomly allocated to three groups at a 1:1:1 ratio in this three-arm parallel, randomized clinical trial. Sixty participants will be randomly allocated to the control group, study group 1 (onsite video) and study group 2 (remote video). The Orthodontic Plaque Index (OPI) and Full-mouth Bleeding Score (FMBS) will be measured at baseline and every two months for up to 12 months. Following data collection, statistical data analysis will be conducted to compare the outcomes and changes between the three groups.

Read the 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.

Being tested
On-site video group, Remote video group
Keywords
Oral hygiene reinforcement, video, fixed orthodontic treatment, adult

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • On-site video groupBehavioural

    Each participant will receive standard oral hygiene reinforcement verbally, followed by watching a pre-recorded oral hygiene instruction video on a tablet

  • Remote video groupBehavioural

    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

Study groups in NCT06162923
Study groupRoleWhat they receive
Control groupNo interventionNot described
On-site video groupExperimentalNot described
Receives: Behavioral: On-site video group
Remote video groupExperimentalNot described
Receives: Behavioral: Remote video group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Orthodontic Plaque Index (OPI)

    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.

    Measured: Every two months for up to 12 months

Secondary outcomes (1)
  1. Full-Mouth Bleeding Score (FMBS)

    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)

    Measured: Every two months for up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2023
  2. Study start1 Apr 2023
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly allocated to three groups (control group, onsite video group and remote video group) at a 1:1:1 ratio in this three-arm parallel.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06162923
Sponsor's protocol ID
DrOrtho LPL
Status last verified
Apr 2024
First submitted
30 Nov 2023
Last updated
29 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing On-site video group and Remote video group in people with Oral Hygiene Reinforcement During Fixed Orthodontic Treatment, run by University of Malaya at 1 site in Malaysia.

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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Phey Ling Lee (+60176988250, phey_ling@hotamil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Orthodontic Plaque Index (OPI) (time frame: Every two months for up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Apr 2024.

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