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

March 26, 2026 updated by: Kumeran A/L Mohan

Mobile Application Push Notification in Improving Oral Hygiene Behaviour in Adolescent Orthodontic Patients: a Randomized Controlled Trial

This research looks at whether using a mobile phone app that sends push-notification reminders can help adolescent orthodontic patients keep their teeth and gums cleaner during treatment.

When teenagers wear braces, it's easy for food and plaque to get stuck around brackets and wires, which can lead to gingivitis and white spot lesions if oral hygiene isn't maintained. Traditional reminders from dentists often fade over time, so this study tests a more consistent, digital approach.

The app sends daily notifications reminding users to brush and care for their teeth. The study will compare three groups:

App with push-notification reminders,

App without reminders, and

Control group with normal instructions only.

Researchers will measure changes in plaque and gum health and use a questionnaire to see if the reminders also improve patients' knowledge, attitude, and practice (KAP) about oral hygiene.

In simple terms, the project tests if short smartphone reminders can make orthodontic patients more consistent, informed, and motivated in caring for their teeth.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kumeran Mohan (Dr), Master of Orthodontics
  • Phone Number: +60164478057
  • Email: kumeran@iium.edu.my

Study Locations

  • Malaysia
    • Pahang
      • Kuantan, Pahang, Malaysia, 25100
        • Recruiting
        • Kulliyyah of Dentistry, International Islamic University Malaysia
        • Contact:
        • Contact:

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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

Exclusion Criteria:

  • 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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ezgigi with push notification
Using mobile app EzGigi WITH DAILY PUSH NOTIFICATION to explain post bond up instructions and advice to watch daily videos posted on oral hygiene instructions and dietary advice
Behavioral: Ezgigi with push notification
Using mobile app EzGigi WITH DAILY PUSH NOTIFICATION to explain post bond up instructions and advice to watch daily videos posted on oral hygiene instructions and dietary advice
Experimental: Ezgigi
Using mobile app EzGigi to explain post bond up instructions and advice to watch daily videos posted on oral hygiene instructions and dietary advice
Behavioral: EzGigi
Using mobile app EzGigi to explain post bond up instructions and advice to watch daily videos posted on oral hygiene instructions and dietary advice
No Intervention: conventional chairside post bond up instruction
Standard chairside post bond up instructions and advice on oral hygiene instructions and dietary advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival health
Time Frame: 6, 12, 18 and 24 weeks

Assess Gingival Index using the scale below:

0 Normal gingiva: pink, firm, no inflammation, no bleeding.

  1. Mild inflammation: slight color change, slight edema, no bleeding on probing.
  2. Moderate inflammation: redness, edema, glazing, bleeding on probing.
  3. Severe inflammation: marked redness, edema, ulceration, spontaneous bleeding.

8 teeth (4 on each arch) will be assessed on all patients. The points are accumulated to assess the gingival condition.
6, 12, 18 and 24 weeks
Plaque amount
Time Frame: 6, 12, 18 and 24 weeks

Orthodontic Plaque Index will be assessed using the following:

0 No visible plaque.

  1. Thin film of plaque detected only by running a probe/explorer.
  2. Visible plaque covering less than one-third of the bracket area.
  3. Heavy plaque accumulation covering more than one-third of the area (thick, clearly visible deposits).

patient's will be asked to chew on a disclosing tablet first, and 4 points will be assessed for each tooth:

  • Gingival area (margin)
  • Mesial area
  • Distal area

  • Occlusal/incisal area

    8 teeth will be assessed (4 each arch). The score is accumulated to assess plaque amount.
6, 12, 18 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral Hygiene and Interdental Cleaning
Time Frame: baseline and 24 weeks
A validated questionnaire of "Knowledge, Attitude and Practice changes in oral hygiene and dietary advice" will be used, with each scored on a Likert scale (1-5). The total points will be calculated.
baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kumeran A/L Mohan

Collaborators

International Islamic University Malaysia

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)

March 26, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMGS25-003-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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