Effect of mHealth Intervention on Oral Health-Related Quality of Life Among Adult Patients With Chronic Systemic Diseases
2 other identifiers
interventional
206
1 country
4
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2025
Shorter than P25 for not_applicable
4 active sites
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
December 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
CompletedFirst Submitted
Initial submission to the registry
September 18, 2026
CompletedFirst Posted
Study publicly available on registry
September 24, 2026
CompletedOctober 1, 2026
September 1, 2026
6 months
September 18, 2026
September 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and 3 months
Secondary Outcomes (3)
Change in Total Oral Health Impact Profile-14 (OHIP-14) Score From Baseline to 1 Month
Baseline and 1 month
Total Oral Health Impact Profile-14 (OHIP-14) Score Trajectory Across the Study Period
Baseline, 1 month, and 3 months
Seven Domain Scores of the Oral Health Impact Profile-14 (OHIP-14)
Baseline, 1 month, and 3 months
Study Arms (2)
mHealth Oral Health Education Intervention
EXPERIMENTALParticipants 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 COMPARATORParticipants received routine care, including the standardized printed oral health education leaflet provided during routine visits, but did not receive the mHealth educational videos.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Al Jabr Kidney Center
Hasa, Eastern Province, 36411, Saudi Arabia
Endocrine and Diabetes Center
Hasa, Eastern Province, 36411, Saudi Arabia
Hereditary Blood Disease Center
Al Mubarraz, 36422, Saudi Arabia
Prince Sultan Cardiac Center
Ḩasā, 36411, Saudi Arabia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2026
First Posted
September 24, 2026
Study Start
December 7, 2025
Primary Completion
May 30, 2026
Study Completion
May 30, 2026
Last Updated
October 1, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
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.