Oral Health LiteracyNCT06734325
Mobile Oral Health Intervention Effectiveness on Orthodontic Patients' Oral Hygiene and Oral Health Literacy
A study testing Mobile Oral Health Intervention in people with Oral Health Literacy and Oral Hygiene, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health Literacy, Oral Hygiene
- What is being tested?
- Mobile Oral Health Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Alexandria University
Alexandria
Nermine Balbaa, BDS, 01271119074 ext. 002, balbaanermine@gmail.com
Nermine M Balbaa, Demonstrator
About this study
Official title: Effectiveness of Mobile Oral Health Intervention on Oral Hygiene and Oral Health Literacy Among Orthodontic Patients: a Randomized Controlled Clinical Trial)
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.
- Conditions
- Oral Health Literacy, Oral Hygiene
- Being tested
- Mobile Oral Health Intervention
- Keywords
- oral health literacy, oral hygiene, orthodontic patients, mobile oral health intervention, whatsapp, messages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Oral Health InterventionBehavioural
46 messages delivered over a 3-month period (12 weeks) via WhatsApp
| Study group | Role | What they receive |
|---|---|---|
| Mobile Oral Health Intervention | Experimental | Mobile oral health intervention in addition to oral hygiene instructions Receives: Behavioral: Mobile Oral Health Intervention |
| Control | No intervention | oral hygiene instructions only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline to 1 month, 3 months, 6 months
Secondary outcomes (1)
Oral Hygiene
assessed by the Silness-Löe Plaque Index (PI) to provide mean PI score for each tooth ranging from 0 to 3.
Measured: Change from baseline to 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start10 Nov 2024
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Health LiteracyStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermine Balbaa, Alexandria University
- Investigators
- Nermine Balbaa, BDS, Principal investigator, Teaching Assistant, Faculty of Dentistry, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734325
- Sponsor's protocol ID
- 0913-05/2024
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38366912Cho 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.
PubMed 32635907Balbaa 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;26(1):113. doi: 10.1186/s12903-025-07423-y.
PubMed 41382113
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mobile Oral Health Intervention on Oral Hygiene and Oral Health Literacy Among Orthodontic Patients: a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06734325
- Acronym / sponsor ID
- 0913-05/2024
- Conditions
- Oral Health Literacy, Oral Hygiene
- Keywords
- oral health literacy, oral hygiene, orthodontic patients, mobile oral health intervention, whatsapp, messages
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Oral Health Intervention | Experimental | Behavioral: Mobile Oral Health InterventionMobile oral health intervention in addition to oral hygiene instructions |
| Control | No intervention | –oral hygiene instructions only |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Oral Health Intervention46 messages delivered over a 3-month period (12 weeks) via WhatsApp | Behavioural | Mobile Oral Health Intervention |
Primary outcome
Oral Health Literacy
Time frame: Change from baseline to 1 month, 3 months, 6 months
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
1 secondary outcome
Oral Hygiene
Time frame: Change from baseline to 1 month, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 38366912Pubalan 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.
- Background: PubMed 32635907Cho 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.
- Derived from this study: PubMed 41382113Balbaa 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;26(1):113. doi: 10.1186/s12903-025-07423-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nermine Balbaa, BDS principal investigator
Teaching Assistant, Faculty of Dentistry, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Oral Health Intervention in people with Oral Health Literacy and Oral Hygiene, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nermine Balbaa, BDS (01271119074 ext. 002, balbaanermine@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Health Literacy (time frame: Change from baseline to 1 month, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06734325, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.