Mobile Oral Health Intervention Effectiveness on Orthodontic Patients' Oral Hygiene and Oral Health Literacy
Effectiveness of Mobile Oral Health Intervention on Oral Hygiene and Oral Health Literacy Among Orthodontic Patients: a Randomized Controlled Clinical Trial)
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2024
Shorter than P25 for not_applicable
1 active site
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 Start
First participant enrolled
November 10, 2024
CompletedFirst Submitted
Initial submission to the registry
December 11, 2024
CompletedFirst Posted
Study publicly available on registry
December 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedDecember 24, 2024
December 1, 2024
6 months
December 11, 2024
December 20, 2024
Conditions
Keywords
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
EXPERIMENTALMobile oral health intervention in addition to oral hygiene instructions
Control
NO INTERVENTIONoral hygiene instructions only
Interventions
46 messages delivered over a 3-month period (12 weeks) via WhatsApp
Eligibility Criteria
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
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: 38366912BACKGROUNDCho 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: 32635907BACKGROUNDBalbaa 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.
PMID: 41382113DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Nermine Balbaa, BDS
Teaching Assistant, Faculty of Dentistry, Alexandria University, Egypt
Central Study Contacts
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