NCT07288853

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

November 24, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 26, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

November 24, 2025

Last Update Submit

March 26, 2026

Conditions

Keywords

push notificationoral hygiene reinforcementfixed orthodontic treamentorthodontic plaque index (OPI)gingival index

Outcome Measures

Primary Outcomes (2)

  • Gingival health

    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

    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 Outcomes (1)

  • Oral Hygiene and Interdental Cleaning

    baseline and 24 weeks

Study Arms (3)

Ezgigi with push notification

EXPERIMENTAL

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

Ezgigi

EXPERIMENTAL

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

conventional chairside post bond up instruction

NO INTERVENTION

Standard chairside post bond up instructions and advice on oral hygiene instructions and dietary advice

Interventions

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

Ezgigi with push notification
EzGigiBEHAVIORAL

Using mobile app EzGigi to explain post bond up instructions and advice to watch daily videos posted on oral hygiene instructions and dietary advice

Ezgigi

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kulliyyah of Dentistry, International Islamic University Malaysia

Kuantan, Pahang, 25100, Malaysia

RECRUITING

MeSH Terms

Conditions

Dental PlaqueGingivitis

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Central Study Contacts

Kumeran Mohan (Dr), Master of Orthodontics

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst Prof Dr

Study Record Dates

First Submitted

November 24, 2025

First Posted

December 17, 2025

Study Start

March 26, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations