An interventional study of mHealth Oral Health Education Intervention and Printed Oral Health Education Leaflet in Hereditary Blood Disorders, Cardiovascular Diseases and Chronic Kidney Disease, sponsored by King Faisal University. Completed at 4 sites in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by King Faisal University · Not applicable, Interventional, and Other
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.
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's enrollment of 206 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →King Faisal University is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: mHealth Oral Health Education Intervention · Behavioral: Printed Oral Health Education Leaflet
Participants received routine care, including the standardized printed oral health education leaflet provided during routine visits, but did not receive the mHealth educational videos.
Behavioral: Printed Oral Health Education Leaflet
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.
A standardized printed oral health education leaflet providing recommendations for daily home oral care, provided as part of routine care.
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.
Time frame: Baseline and 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 month, and 3 months
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Dec 2025 to primary completion in May 2026, 5 months.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 5 months is below that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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King Faisal University