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

NCT06162923 | Recruiting

• 1 other identifier: DrOrtho LPL
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Oral Hygiene Reinforcement During Fixed Orthodontic Treatment

Keywords

Oral hygiene reinforcement; video; fixed orthodontic treatment; adult

Outcome Measures

Primary Outcomes (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.

  Every two months for up to 12 months

Secondary Outcomes (1)

• Full-Mouth Bleeding Score (FMBS)

  Every two months for up to 12 months

Study Arms (3)

Control group

NO INTERVENTION

On-site video group

EXPERIMENTAL

Behavioral: On-site video group

Remote video group

EXPERIMENTAL

Behavioral: Remote video group

Interventions

On-site video group BEHAVIORAL

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

On-site video group

Remote video group BEHAVIORAL

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

Remote video group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, 50603, Malaysia

RECRUITING

Central Study Contacts

Phey Ling Lee

CONTACT

+60176988250; phey_ling@hotamil.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a randomised, single-blind clinical trial. Because the allocation sequence and types of interventions delivered to the participants will be performed by an independent clinician, the main investigator can be blinded to the types of interventions that the participants will receive. The main clinician will be in charge of data collection. The data will be passed to the independent clinician once the main clinician has completed data collection. The data will be entered into the Data Collection Sheet by the independent clinician, who will also generate coding for the participants' names and types of interventions. The data is then passed to the main clinician for analysis. As a result, the main clinician is also blinded during the data analysis stage
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: April 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

MY (1)