Mobile Application Push Notification in Improving Oral Hygiene Behaviour in Adolescent Orthodontic Patients

General objective:

To evaluate the effectiveness of push notification oral hygiene reminders on oral hygiene improvement and behavioural changes

Specific objectives:

To evaluate the oral hygiene improvement using push notification in a mobile phone application To assess the improvement in knowledge, attitude and practice (KAP) towards oral hygiene using push notification reminders in a mobile phone application

Study Design This is a 3-arm parallel-group randomized controlled trial (RCT) to evaluate the effectiveness of push notification-based oral hygiene reminders on oral hygiene improvement and behavioural changes among orthodontic patients with fixed appliances.

Trial setting The will be single centred study conducted in the Postgraduate Orthodontic Clinic, International Islamic University Malaysia, Kuantan Campus.

Ethical consideration Ethics approval will be acquired from the IIUM Research Ethics Committee (IREC) before study commencement. This study will also be in line with the CONSORT guidelines. Written informed consent will be obtained from each participant, ensuring full comprehension of study aims, procedures, risks, and benefits. Participants' data confidentiality will be maintained, adhering to the Declaration of Helsinki.

Eligibility criteria Inclusion criteria Exclusion criteria Aged 12-18 years Suitable for upper and lower arch fixed appliance treatment Good oral hygiene Able to understand Bahasa Malaysia and/or English Possess a personal or parental smartphone with app access Medically compromised or syndromic patients Need to skip bracket bonding On antibiotics Undergoing periodontal therapy Already using another dental reminder or behavior-change app Patients with cognitive or developmental limitations preventing app use

Intervention and comparator Arm 1: Access to the EzGiGi app, and daily behavioural and motivational push notification reminders Arm 2: Access to the EzGiGi app only Arm 3: No digital intervention Conduct of study Eligible patient will be identified through screening during initial pre-orthodontic assessment by the treating orthodontists or postgraduate orthodontic residents, during which relevant records such as a thorough intraoral assessment of dental and gingival health, intraoral and extraoral photographs, study models, and radiographs (dental panoramic radiographs and lateral cephalometric radiographs) are taken.

Upon selection, and obtaining informed consent, patient will be allocated to a randomly assigned treatment group. Fixed appliance treatment commences with upper and lower arch bond up using conventional metal brackets and round Nickel Titanium archwires. The patient will be required to complete a KAP questionnaire. Post operative instructions are then given, with the assigned mode of oral health knowledge reminder, according to their allocated group.

Patients' follow up visits are every 6 weeks. During these visits, Plaque Index and Gingival Index are also done at 6, 12, 18, 24 weeks. A follow-up KAP questionnaire on the patient's dental health knowledge is also done at 24 weeks. Once the study closes out, the fixed appliance treatment will be continued to completion.

Outcomes

Primary outcomes Orthodontic Plaque Index The Orthodontic Plaque index is used to assess the amount of dental plaque which accumulates around the bracket and bands of a fixed appliance. The index consists of scoring system as below.

Score 0: No plaque visible around bracket. Score 1: Plaque covering less than 1/3 of the bracket area. Score 2: Plaque covering between 1/3 and 2/3 of the bracket area. Score 3: Plaque covering more than 2/3 of the bracket area.

Patients will first be asked to chew on a disclosing tablet to identify the plaque clearly. An accumulated score is taken from 6 teeth (16, 11, 25, 36, 31, 45) and then averaged to conclude an overall plaque index value. If any of the teeth mentioned has been extracted, then the adjacent tooth will be used.

This step will be done during baseline, week 6, 12, 18 and 24.

Gingival Index The Gingival Index is a widely used measurement tool to assess gingival health of patients. Assessment is done based on colour, oedema and bleeding on probing. The index consists of the following scoring system.

Score 0: Normal gingiva (no inflammation pink firm). Score 1: Mild inflammation (slight change in color slight edema no bleeding on probing).

Score 2: Moderate inflammation (redness edema glazing bleeding on probing). Score 3: Severe inflammation (marked redness edema ulceration spontaneous bleeding).

The assessment will be done based on the visual assessment (to assess colour and oedema) and gingival probing using a periodontal probe (to assess spontaneous or delayed bleeding on probing) This step will be done during baseline, week 6, 12, 18 and 24.

Secondary outcomes Knowledge, Attitude and Practice questionnaire The KAP Questionnaire on Oral Hygiene and Interdental Cleaning is a validated, bilingual, self-administered questionnaire where questions will be marked (correct or incorrect). Finally, the accumulated percentage will be calculated. This questionnaire will be administered during baseline and at 24 weeks of treatment.

• Oral Hygiene and Interdental Cleaning [Срок оценки: baseline and 24 weeks]