NCT06734325

Brief Summary

Orthodontic patients face unique challenges in maintaining optimal oral hygiene due to the presence of fixed orthodontic appliances, which tend to increase plaque retention, leading to gingival inflammation. Oral Health Literacy (OHL) plays a role in an individual's ability to understand and implement oral hygiene instructions effectively. Mobile oral health interventions involve the use of mobile technology such as smartphones to improve oral hygiene practices and outcomes. Aim of the study: To assess the effectiveness of a mobile oral health intervention using WhatsApp messages as compared to standard oral hygiene instructions on oral hygiene status and OHL level among orthodontic patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

December 11, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

oral health literacyoral hygieneorthodontic patientsmobile oral health interventionwhatsappmessages

Outcome Measures

Primary Outcomes (1)

  • Oral Health Literacy

    oral health literacy as measured by the Oral Health Literacy - Adult Questionnaire (OHL-AQ). Scores of all questions answered by participants will be added to obtain the overall score of OHL ranging from 0 to 17. Scores are categorized into three groups: Inadequate (0-9), Borderline (10-11), and Adequate (12-17) OHL level

    Change from baseline to 1 month, 3 months, 6 months

Secondary Outcomes (1)

  • Oral Hygiene

    Change from baseline to 1 month, 3 months, 6 months

Study Arms (2)

Mobile Oral Health Intervention

EXPERIMENTAL

Mobile oral health intervention in addition to oral hygiene instructions

Behavioral: Mobile Oral Health Intervention

Control

NO INTERVENTION

oral hygiene instructions only

Interventions

46 messages delivered over a 3-month period (12 weeks) via WhatsApp

Mobile Oral Health Intervention

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients undergoing orthodontic treatment with fixed appliances in both arches for the first time.
  • Patients between the age of 16 and 25 years.
  • Participants must own a smartphone with WhatsApp installed.
  • Those who agree to be part of the research project and accept the informed consent.

You may not qualify if:

  • The presence of systemic diseases affecting oral health.
  • Patients with cleft lip and/or palate.
  • Functional and orthognathic patients.
  • Previous orthodontic treatment.
  • Patients with a removable appliance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

RECRUITING

Related Publications (3)

  • Pubalan S, Zi Hong O, Yongxian T, Mabel L. Assessing effectiveness of WhatsApp messaging program in oral hygiene care for orthodontic patients: A randomised controlled trial. J Orthod. 2024 Dec;51(4):407-414. doi: 10.1177/14653125241230561. Epub 2024 Feb 17.

    PMID: 38366912BACKGROUND
  • Cho HA, Im AJ, Sim YR, Jang HB, Lim HJ. The association between oral health literacy and oral health behaviors in North Korean defectors: a cross-sectional study. BMC Public Health. 2020 Jul 7;20(1):1074. doi: 10.1186/s12889-020-08550-7.

    PMID: 32635907BACKGROUND
  • Balbaa NM, Hamza MA, Abdelaziz WE, Adham MM. Effectiveness of mobile oral health intervention on orthodontic patients' oral hygiene and oral health literacy: a randomised controlled clinical trial. BMC Oral Health. 2025 Dec 12. doi: 10.1186/s12903-025-07423-y. Online ahead of print.

Study Officials

  • Nermine Balbaa, BDS

    Teaching Assistant, Faculty of Dentistry, Alexandria University, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nermine Balbaa, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 16, 2024

Study Start

November 10, 2024

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

December 24, 2024

Record last verified: 2024-12

Locations