An interventional study of Standardized Face-to-Face Oral Health Education and WhatsApp-Based Oral Health Messages in Oral Health, Dental Caries and Health Behavior, sponsored by King Abdulaziz University. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by King Abdulaziz University · Not applicable, Interventional, and Prevention
Tooth decay is one of the most common health problems in young children in Saudi Arabia. Brushing twice a day with fluoride toothpaste is one of the most effective ways to prevent it, but preschool children cannot do this properly on their own and depend on their mothers to brush for them and to supervise them. Mothers usually receive oral health advice only once, during a dental visit, and a single session may not be enough to change daily habits at home.
This study will test whether short oral health messages sent to mothers on WhatsApp, in addition to the usual face-to-face advice, help mothers know more about toothbrushing and help their children brush better.
Mothers of children aged 3 to 6 years attending the Pediatric Dentistry Clinics at King Abdulaziz University Hospital in Jeddah will be invited to take part. All mothers will first answer a short questionnaire about what they know about toothbrushing and how their child currently brushes. All mothers will then receive the same 10 to 15 minute face-to-face oral health education session. After the session, each mother will be placed into one of two groups by chance, like flipping a coin. Mothers in the first group will also receive two WhatsApp messages a week for eight weeks, sixteen messages in total, covering how often to brush, how much fluoride toothpaste to use, correct brushing technique, and how to help and supervise their child. Mothers in the second group will not receive these messages.
After eight weeks, all mothers will answer the same questionnaire again, and the answers of the two groups will be compared. Taking part involves no dental treatment or procedures beyond the child's normal care, and mothers may withdraw at any time.
This is an open-label, two-arm, parallel-group randomized controlled trial with 1:1 allocation, conducted at the Pediatric Dentistry Clinics of King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
Mothers of children aged 3 to 6 years will be approached in the clinic waiting area. After electronic informed consent, participants will complete a baseline self-administered questionnaire delivered through Google Forms on their own smartphones, covering demographic characteristics, maternal oral health knowledge, and child toothbrushing behavior. All participants will then receive a standardized 10 to 15 minute individual face-to-face oral health education session delivered in Arabic by the principal investigator, using visual materials from the American Academy of Pediatric Dentistry and the Saudi Ministry of Health.
Randomization will follow the baseline questionnaire and education session. A computer-generated block randomization sequence with varying block sizes of 4, 6, and 8 will be prepared in advance by an independent person not involved in recruitment or data collection, and concealed in sequentially numbered, opaque, sealed envelopes opened only after baseline assessment and education are complete.
Participants allocated to the intervention arm will additionally receive individually delivered WhatsApp messages twice weekly for eight weeks, sixteen messages in total, reinforcing the same toothbrushing content covered in the education session. Messages will be delivered in Arabic and may include text, images, or short videos drawn from evidence-based sources; all content will be reviewed by a pediatric dentist before delivery. Participants allocated to the control arm will receive the face-to-face education session only, with no further contact during the intervention period.
At eight weeks, all participants will be invited by WhatsApp to complete the same questionnaire through a secure Google Forms link, omitting the demographic and eligibility sections. Non-responders will receive up to three reminders at 3 to 5 days, 7 to 10 days, and 14 days after the initial invitation, after which they will be classified as lost to follow-up.
Blinding of participants and of the investigator is not feasible given the nature of the intervention, so the trial is open-label. Analysis will follow the intention-to-treat principle and will use analysis of covariance comparing eight-week scores between arms with the corresponding baseline score as covariate; results will be reported as adjusted mean differences with 95% confidence intervals. Missing follow-up data will be handled by multiple imputation under a missing-at-random assumption, with estimates pooled using Rubin's rules.
The target sample size of 106 participants, 53 per arm, was derived for ANCOVA with alpha of 0.05, power of 0.80, effect size f of 0.31, and one covariate, giving 42 per arm before inflation for 20 percent anticipated attrition.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
This study's planned enrollment of 106 is above the median of 60 across 967 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →King Abdulaziz University is the lead sponsor of 98 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 receive a single standardized face-to-face oral health education session and, in addition, WhatsApp-based oral health messages delivered twice weekly for eight weeks (16 messages total) reinforcing toothbrushing recommendations. Assigned interventions: Behavioral: Standardized Face-to-Face Oral Health Education; Behavioral: WhatsApp-Based Oral Health Messages
Behavioral: Standardized Face-to-Face Oral Health Education · Behavioral: WhatsApp-Based Oral Health Messages
Participants receive the same single standardized face-to-face oral health education session and no additional oral health education or messages during the eight-week study period. Assigned intervention: Behavioral: Standardized Face-to-Face Oral Health Education
Behavioral: Standardized Face-to-Face Oral Health Education
A single individual education session of 10 to 15 minutes delivered in Arabic by the principal investigator immediately after baseline assessment, covering the importance of toothbrushing, recommended frequency and timing, use of fluoridated toothpaste, proper brushing technique, parental assistance and supervision, and toothbrush selection and maintenance, supported by standardized visual materials. Arms: Both arms
Sixteen oral health messages delivered individually via WhatsApp in Arabic, two per week for eight weeks, reinforcing the toothbrushing content of the education session. Messages may include text, images, or short videos from evidence-based sources including the American Academy of Pediatric Dentistry and the American Dental Association, and are reviewed by a pediatric dentist before delivery. Arms: Experimental arm only
Maternal oral health knowledge score
Maternal knowledge of toothbrushing-related oral health recommendations, measured by an eight-item multiple-choice questionnaire covering timing of toothbrushing, initiation of toothbrushing, parental positioning during brushing, fluoride toothpaste use, recommended fluoride concentration, parental supervision, consequences of inadequate toothbrushing, and toothbrush selection. Each correct answer scores 1 point; incorrect and "I do not know" answers score 0. Total score ranges from 0 to 8, with higher scores indicating greater oral health knowledge.
Time frame: Baseline and 8 weeks after the education session
Child toothbrushing behavior score (maternal report)
Toothbrushing behavior of the designated study child as reported by the mother, measured by an eight-item questionnaire covering brushing frequency, fluoride toothpaste use, amount of toothpaste, parental involvement during brushing, brushing of all tooth surfaces, brushing duration, toothbrush replacement practices, and post-brushing behavior. Responses consistent with current evidence-based recommendations score 1 point and all other responses score 0. Total score ranges from 0 to 8, with higher scores indicating more favorable toothbrushing practices. Children reported as not brushing are assigned a score of 0.
Time frame: Baseline and 8 weeks after the education session
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared publicly. De-identified data may be made available from the corresponding author on reasonable request.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Apr 2027, 8 months later.
Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 8 months is below that.
Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
King Abdulaziz University