Hereditary Blood DisordersNCT07839429
Effect of mHealth Intervention on Oral Health-Related Quality of Life Among Adult Patients With Chronic Systemic Diseases
A study testing mHealth Oral Health Education Intervention and Printed Oral Health Education Leaflet in people with Hereditary Blood Disorders and Cardiovascular Diseases, run by King Faisal University at 4 sites in Saudi Arabia.
Trial summary
This study evaluated whether an mHealth oral health education intervention could improve oral health-related quality of life among adults with chronic systemic diseases registered in specialized disease centers in Al-Ahsa, Saudi Arabia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Blood Disorders, Cardiovascular Diseases, Chronic Kidney Disease
- What is being tested?
- mHealth Oral Health Education Intervention and Printed Oral Health Education Leaflet
- 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
- 206 participants
- Where
- 4 sitesSaudi Arabia
- Study dates
- 7 Dec 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Registered at one of the participating specialized disease centers in Al-Ahsa, Saudi Arabia.
- Physician-confirmed diagnosis of type 1 diabetes mellitus, cardiovascular disease, chronic kidney disease, or a hereditary blood disorder.
- Medically stable at the time of enrollment.
- Has access to a smartphone and the internet.
- Able to understand Arabic.
- Provides electronic informed consent.
- Willing and able to participate for the 3-month study period.
Who cannot join
- Unable to use a smartphone or access the digital intervention.
- Cognitive or psychiatric impairment that could interfere with participation or completion of study assessments.
- Severe disability that prevents participation in the study procedures.
- Completely edentulous.
- Pregnant at the time of enrollment.
- Currently enrolled in another oral health intervention study.
- Planning to relocate during the 3-month study period.
- Medically unstable or considered unsuitable for participation based on clinical assessment.
Trial locations and contacts
4 sites in 1 country.
Saudi Arabia4 sites
Hereditary Blood Disease Center
Al Mubarraz, 36422
Al Jabr Kidney Center
Hasa, Eastern Province, 36411
Endocrine and Diabetes Center
Hasa, Eastern Province, 36411
Prince Sultan Cardiac Center
Ḩasā, 36411
About this study
Official title: Effect of mHealth Intervention on Oral Health-Related Quality of Life Among Adult Patients Registered in Specialized Disease Centers in Al-Ahsa, Saudi Arabia: A Quasi-Experimental Pragmatic Study.
This study evaluated whether an mHealth oral health education intervention could improve oral health-related quality of life among adults with chronic systemic diseases registered in specialized disease centers in Al-Ahsa, Saudi Arabia. Adults with type 1 diabetes mellitus, cardiovascular disease, chronic kidney disease, or hereditary blood disorders were included.
Participants were assigned to either an intervention group or a control group. Both groups continued to receive routine care. The control group received a standardized printed oral health education leaflet, while the intervention group received an mHealth oral health education program consisting of five educational videos covering toothbrush and fluoride toothpaste selection, toothbrushing technique, dental flossing, tongue cleaning, and water flosser use. The educational materials were delivered electronically through a secure web-based platform, with links sent through WhatsApp at regular intervals during the 3-month intervention period.
Oral health-related quality of life was assessed using the validated Arabic version of the 14-item Oral Health Impact Profile (OHIP-14) at baseline, 1 month, and 3 months. The main hypothesis was that participants receiving the mHealth intervention would show greater improvement in oral health-related quality of life over the 3-month study period compared with participants receiving the control condition.
Read the detailed description
This pragmatic quasi-experimental study was conducted among adult patients registered in four specialized disease centers in Al-Ahsa, Saudi Arabia: the Endocrinology and Diabetes Center, Prince Sultan Center for Cardiac Diseases and Surgery, Al-Jaber Kidney Center, and Hereditary Blood Diseases Center. The study population included adults with type 1 diabetes mellitus, cardiovascular disease, chronic kidney disease, or hereditary blood disorders.
Eligible participants provided electronic informed consent before participation. Following baseline assessment, participants were assigned to parallel intervention and control groups. The intervention lasted 3 months, with assessments conducted at baseline (T0), 1 month (T1), and 3 months (T2).
Participants in both groups continued their routine health care. The control group received a standardized printed oral health education leaflet containing recommendations for daily home oral care. In addition to routine care, the intervention group received five Arabic educational videos addressing toothbrush and fluoride toothpaste selection, toothbrushing technique, dental flossing, tongue cleaning, and water flosser use. The intervention was delivered through a secure web-based platform, and access links were sent through WhatsApp. The educational package was re-sent every 2 weeks during the intervention period to reinforce exposure to the educational content.
Oral health-related quality of life was measured using the validated Arabic version of the 14-item Oral Health Impact Profile (OHIP-14). Assessments were completed at baseline, 1 month, and 3 months. The principal comparison focused on differences between the intervention and control groups in change in total OHIP-14 score from baseline to the 3-month assessment. Additional analyses examined OHIP-14 over the study period and its relationship with selected participant characteristics.
- Conditions
- Hereditary Blood Disorders, Cardiovascular Diseases, Chronic Kidney Disease, Diabete Mellitus
- Being tested
- mHealth Oral Health Education Intervention, Printed Oral Health Education Leaflet
- Keywords
- Oral Health-Related Quality of Life, Oral Health Impact Profile, mHealth, Saudi Arabia, Chronic Systemic Diseases, Oral Health Education
- Medical subject headings
- Cardiovascular Diseases, Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Oral Health Education InterventionBehavioural
A 3-month Arabic mHealth oral health education intervention consisting of five educational videos covering toothbrush and fluoride toothpaste selection, toothbrushing technique, dental flossing, tongue cleaning, and water flosser use. The videos were delivered through a secure web-based platform, with access links sent via WhatsApp. The complete educational package was provided at baseline and re-sent every 2 weeks through week 10. Participants continued to receive their usual care throughout the study.
Printed Oral Health Education LeafletBehavioural
A standardized printed oral health education leaflet providing recommendations for daily home oral care, provided as part of routine care.
| Study group | Role | What they receive |
|---|---|---|
| mHealth Oral Health Education Intervention | Experimental | Participants received routine care, including the standardized printed oral health education leaflet provided during routine visits, plus a 3-month mHealth oral health education intervention consisting of five Arabic educational videos. Receives: Behavioral: mHealth Oral Health Education Intervention; Behavioral: Printed Oral Health Education Leaflet |
| Control | Active comparator | Participants received routine care, including the standardized printed oral health education leaflet provided during routine visits, but did not receive the mHealth educational videos. Receives: Behavioral: Printed Oral Health Education Leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Oral Health Impact Profile-14 (OHIP-14) Score From Baseline to 3 Months
Oral health-related quality of life was assessed using the validated Arabic version of the 14-item Oral Health Impact Profile (OHIP-14). Each item is scored from 0 to 4, yielding a total score ranging from 0 to 56. Higher scores indicate poorer oral health-related quality of life. The outcome is the change in total OHIP-14 score from baseline to 3 months, compared between the intervention and control groups.
Measured: Baseline and 3 months
Secondary outcomes (3)
Change in Total Oral Health Impact Profile-14 (OHIP-14) Score From Baseline to 1 Month
Oral health-related quality of life was assessed using the validated Arabic version of the 14-item Oral Health Impact Profile (OHIP-14). Each item is scored from 0 to 4, yielding a total score ranging from 0 to 56. Higher scores indicate poorer oral health-related quality of life. This outcome assesses the change in total OHIP-14 score from baseline to 1 month and compares the change between the intervention and control groups.
Measured: Baseline and 1 month
Total Oral Health Impact Profile-14 (OHIP-14) Score Trajectory Across the Study Period
Oral health-related quality of life was assessed using the validated Arabic version of the 14-item Oral Health Impact Profile (OHIP-14) at baseline, 1 month, and 3 months. Total scores range from 0 to 56, with higher scores indicating poorer oral health-related quality of life. This outcome evaluates changes in total OHIP-14 score across the three assessment time points.
Measured: Baseline, 1 month, and 3 months
Seven Domain Scores of the Oral Health Impact Profile-14 (OHIP-14)
The seven domains of the Arabic OHIP-14 were assessed separately: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Each domain consists of two items scored from 0 to 4, yielding a domain score ranging from 0 to 8. Higher domain scores indicate a greater negative impact on oral health-related quality of life. Domain scores were assessed separately at baseline, 1 month, and 3 months to evaluate changes over the study period.
Measured: Baseline, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start7 Dec 2025
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Blood DisordersStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to one of two parallel groups: an intervention group receiving an mHealth oral health education intervention in addition to usual care, or a control group receiving usual care and a standardized printed oral health education leaflet. Participants were followed for three months, with assessments at baseline, one month, and three months.
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839429
- Sponsor's protocol ID
- KFU-REC-2025-AUG -ETHICS3521
- Other IDs
- IRB-KFHH No. (H-05-HS-065)
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because data sharing was not included in the approved study protocol or informed consent. Aggregated study findings will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of mHealth Intervention on Oral Health-Related Quality of Life Among Adult Patients Registered in Specialized Disease Centers in Al-Ahsa, Saudi Arabia: A Quasi-Experimental Pragmatic Study.
- ClinicalTrials.gov ID
- NCT07839429
- Acronym / sponsor ID
- KFU-REC-2025-AUG -ETHICS3521
- Conditions
- Hereditary Blood Disorders, Cardiovascular Diseases, Chronic Kidney Disease, Diabete Mellitus
- Keywords
- Oral Health-Related Quality of Life, Oral Health Impact Profile, mHealth, Saudi Arabia, Chronic Systemic Diseases, Oral Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- King Faisal UniversityUniversity, hospital or other
- Study start
- 7 Dec 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 24 Sep 2026 (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.
This study evaluated whether an mHealth oral health education intervention could improve oral health-related quality of life among adults with chronic systemic diseases registered in specialized disease centers in Al-Ahsa, Saudi Arabia. Adults with type 1 diabetes mellitus, cardiovascular disease, chronic kidney disease, or hereditary blood disorders were included.
Participants were assigned to either an intervention group or a control group. Both groups continued to receive routine care. The control group received a standardized printed oral health education leaflet, while the intervention group received an mHealth oral health education program consisting of five educational videos covering toothbrush and fluoride toothpaste selection, toothbrushing technique, dental flossing, tongue cleaning, and water flosser use. The educational materials were delivered electronically through a secure web-based platform, with links sent through WhatsApp at regular intervals during the 3-month intervention period.
Oral health-related quality of life was assessed using the validated Arabic version of the 14-item Oral Health Impact Profile (OHIP-14) at baseline, 1 month, and 3 months. The main hypothesis was that participants receiving the mHealth intervention would show greater improvement in oral health-related quality of life over the 3-month study period compared with participants receiving the control condition.
Detailed description
This pragmatic quasi-experimental study was conducted among adult patients registered in four specialized disease centers in Al-Ahsa, Saudi Arabia: the Endocrinology and Diabetes Center, Prince Sultan Center for Cardiac Diseases and Surgery, Al-Jaber Kidney Center, and Hereditary Blood Diseases Center. The study population included adults with type 1 diabetes mellitus, cardiovascular disease, chronic kidney disease, or hereditary blood disorders.
Eligible participants provided electronic informed consent before participation. Following baseline assessment, participants were assigned to parallel intervention and control groups. The intervention lasted 3 months, with assessments conducted at baseline (T0), 1 month (T1), and 3 months (T2).
Participants in both groups continued their routine health care. The control group received a standardized printed oral health education leaflet containing recommendations for daily home oral care. In addition to routine care, the intervention group received five Arabic educational videos addressing toothbrush and fluoride toothpaste selection, toothbrushing technique, dental flossing, tongue cleaning, and water flosser use. The intervention was delivered through a secure web-based platform, and access links were sent through WhatsApp. The educational package was re-sent every 2 weeks during the intervention period to reinforce exposure to the educational content.
Oral health-related quality of life was measured using the validated Arabic version of the 14-item Oral Health Impact Profile (OHIP-14). Assessments were completed at baseline, 1 month, and 3 months. The principal comparison focused on differences between the intervention and control groups in change in total OHIP-14 score from baseline to the 3-month assessment. Additional analyses examined OHIP-14 over the study period and its relationship with selected participant characteristics.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two parallel groups: an intervention group receiving an mHealth oral health education intervention in addition to usual care, or a control group receiving usual care and a standardized printed oral health education leaflet. Participants were followed for three months, with assessments at baseline, one month, and three months.
| Arm | Type | Receives |
|---|---|---|
| mHealth Oral Health Education Intervention | Experimental | Behavioral: mHealth Oral Health Education Intervention, Behavioral: Printed Oral Health Education LeafletParticipants received routine care, including the standardized printed oral health education leaflet provided during routine visits, plus a 3-month mHealth oral health education intervention consisting of five Arabic educational videos. |
| Control | Active comparator | Behavioral: Printed Oral Health Education LeafletParticipants received routine care, including the standardized printed oral health education leaflet provided during routine visits, but did not receive the mHealth educational videos. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 years or older.
- Registered at one of the participating specialized disease centers in Al-Ahsa, Saudi Arabia.
- Physician-confirmed diagnosis of type 1 diabetes mellitus, cardiovascular disease, chronic kidney disease, or a hereditary blood disorder.
- Medically stable at the time of enrollment.
- Has access to a smartphone and the internet.
Key exclusion criteria (8 listed)
- Unable to use a smartphone or access the digital intervention.
- Cognitive or psychiatric impairment that could interfere with participation or completion of study assessments.
- Severe disability that prevents participation in the study procedures.
- Completely edentulous.
- Pregnant at the time of enrollment.
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 |
|---|---|---|
| mHealth Oral Health Education InterventionA 3-month Arabic mHealth oral health education intervention consisting of five educational videos covering toothbrush and fluoride toothpaste selection, toothbrushing technique, dental flossing, tongue cleaning, and water flosser use. The videos were delivered through a secure web-based platform, with access links sent via WhatsApp. The complete educational package was provided at baseline and re-sent every 2 weeks through week 10. Participants continued to receive their usual care throughout the study. | Behavioural | mHealth Oral Health Education Intervention |
| Printed Oral Health Education LeafletA standardized printed oral health education leaflet providing recommendations for daily home oral care, provided as part of routine care. | Behavioural | Control, mHealth Oral Health Education Intervention |
Primary outcome
Change in Total Oral Health Impact Profile-14 (OHIP-14) Score From Baseline to 3 Months
Time frame: Baseline and 3 months
Oral health-related quality of life was assessed using the validated Arabic version of the 14-item Oral Health Impact Profile (OHIP-14). Each item is scored from 0 to 4, yielding a total score ranging from 0 to 56. Higher scores indicate poorer oral health-related quality of life. The outcome is the change in total OHIP-14 score from baseline to 3 months, compared between the intervention and control groups.
3 secondary outcomes
Change in Total Oral Health Impact Profile-14 (OHIP-14) Score From Baseline to 1 Month
Time frame: Baseline and 1 month
Total Oral Health Impact Profile-14 (OHIP-14) Score Trajectory Across the Study Period
Time frame: Baseline, 1 month, and 3 months
Seven Domain Scores of the Oral Health Impact Profile-14 (OHIP-14)
Time frame: Baseline, 1 month, and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because data sharing was not included in the approved study protocol or informed consent. Aggregated study findings will be reported in scientific publications.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Oral Health Education Intervention and Printed Oral Health Education Leaflet in people with Hereditary Blood Disorders and Cardiovascular Diseases, run by King Faisal University at 4 sites in Saudi Arabia.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Oral Health Impact Profile-14 (OHIP-14) Score From Baseline to 3 Months (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.