Caries,DentalNCT06649760
Oral Health Education and Message Framing Effect on Oral Health Status of Refugees in Egypt
A study testing Gain and loss framed mobile text messages in people with Caries,Dental and Plaque, Dental, run by Alexandria University at 1 site in Egypt.
Trial summary
Refugees, facing forced displacement and often exposed to traumatic experiences, represent a vulnerable population with unique healthcare needs. Oral health is considered a prominent factor that contributes to quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caries,Dental, Plaque, Dental, Gingivitis
- What is being tested?
- Gain and loss framed mobile text messages
- 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
- 303 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2024to 13 Dec 2025
- 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
- Refugees older than 18 years old.
- From Arabic speaking countries.
- Has been resident in Alexandria, Egypt for at least 6 months.
- Having mobile phones to receive text messages.
- Agrees to participate in the study.
Who cannot join
- Planning to move away during 1 year study period.
- Participating in any kind of oral health education and promotion programs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Message Framing Through M-Health on Oral Health Conditions and Oral Health Related Quality of Life Among Refugees in Alexandria, Egypt: A Randomized Controlled Clinical Trial
Refugees, facing forced displacement and often exposed to traumatic experiences, represent a vulnerable population with unique healthcare needs. Oral health is considered a prominent factor that contributes to quality of life.
Therefore, this study aim at assessing the effect of message framing on enhancing oral health practices in a group of refugees in Alexandria, Egypt. A three-arm cluster randomized controlled clinical trial will compare a gain-framed mobile text messages group, a loss-framed mobile text messages group, and a control group. The primary outcome is the improvement in oral health practices measured by changes in dental plaque and secondary outcome is to assess change in oral health-related quality of life. In addition, oral health knowledge, attitudes, and practices of refugees will be assessed.
- Conditions
- Caries,Dental, Plaque, Dental, Gingivitis, Oral Health Quality of Life (OHQoL) Was Assessed
- Being tested
- Gain and loss framed mobile text messages
- Keywords
- Dental caries, Plaque, Gingivitis
- Medical subject headings
- Dental Caries, Dental Plaque, Gingivitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gain and loss framed mobile text messagesBehavioural
To assess the effect of message framing on enhancing oral health practices in a group of refugees
| Study group | Role | What they receive |
|---|---|---|
| Gain-framed messages | Experimental | The participants will receive every 2 weeks a boosting reminder mobile text message in a gain-framed way. For example, "Great breath, healthy gums only a toothbrush away" "flossing your teeth daily removes particles of food in the mouth, avoiding bacteria, which promotes great breath." Receives: Behavioral: Gain and loss framed mobile text messages |
| Loss-framed message | Experimental | he participants will receive every 2 weeks a boosting reminder mobile text message in a loss-framed way. For example, "Brush now and avoid bad breath and gum disease", "If you don't floss your teeth daily, particles of food remain in the mouth, collecting bacteria, which causes bad breath." Receives: Behavioral: Gain and loss framed mobile text messages |
| Control group | No intervention | Participants allocated to this group will not receive mobile text messages. They will only receive the oral health education session given to all participants at the beginning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health-related quality of life improvement
To assess change in OHRQL using OHIP
Measured: Immediately after structured oral health session, 6 months and 1 year after baseline
Oral health practices improvement
Assess toothbrushing and flossing frequency before and after the education session and reminder mobile messages
Measured: 6 months and 1 year after baseline
Oral hygiene status assesment
measure the change in plaque index scores among participants
Measured: 6 months and 1 year after baseline
Gingival health assessment
measure the change in gingival index scores among participants
Measured: 6 months and 1 year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start15 Nov 2024
- Primary completion12 Dec 2025
- Study completion13 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries,DentalStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Youssef Attia, Alexandria University
- Investigators
- Mona El Kashlan, Professor, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649760
- Sponsor's protocol ID
- Refugees oral health education
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol and assessment forms.
Publications
Attia D, ElKashlan MK, Saleh SM, Adham MM. Effect of framed mHealth messages on oral hygiene and quality of life among Sudanese refugees in Egypt: a randomized controlled trial. BMC Oral Health. 2026 Jul 17;26(1):1275. doi: 10.1186/s12903-026-09252-z.
PubMed 42464234
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Message Framing Through M-Health on Oral Health Conditions and Oral Health Related Quality of Life Among Refugees in Alexandria, Egypt: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06649760
- Acronym / sponsor ID
- Refugees oral health education
- Conditions
- Caries,Dental, Plaque, Dental, Gingivitis, Oral Health Quality of Life (OHQoL) Was Assessed
- Keywords
- Dental caries, Plaque, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 13 Dec 2025 (actual)
- First posted
- 21 Oct 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.
Refugees, facing forced displacement and often exposed to traumatic experiences, represent a vulnerable population with unique healthcare needs. Oral health is considered a prominent factor that contributes to quality of life.
Therefore, this study aim at assessing the effect of message framing on enhancing oral health practices in a group of refugees in Alexandria, Egypt. A three-arm cluster randomized controlled clinical trial will compare a gain-framed mobile text messages group, a loss-framed mobile text messages group, and a control group. The primary outcome is the improvement in oral health practices measured by changes in dental plaque and secondary outcome is to assess change in oral health-related quality of life. In addition, oral health knowledge, attitudes, and practices of refugees will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gain-framed messages | Experimental | Behavioral: Gain and loss framed mobile text messagesThe participants will receive every 2 weeks a boosting reminder mobile text message in a gain-framed way. For example, "Great breath, healthy gums only a toothbrush away" "flossing your teeth daily removes particles of food in the mouth, avoiding bacteria, which promotes great breath." |
| Loss-framed message | Experimental | Behavioral: Gain and loss framed mobile text messageshe participants will receive every 2 weeks a boosting reminder mobile text message in a loss-framed way. For example, "Brush now and avoid bad breath and gum disease", "If you don't floss your teeth daily, particles of food remain in the mouth, collecting bacteria, which causes bad breath." |
| Control group | No intervention | –Participants allocated to this group will not receive mobile text messages. They will only receive the oral health education session given to all participants at the beginning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Refugees older than 18 years old.
- From Arabic speaking countries.
- Has been resident in Alexandria, Egypt for at least 6 months.
- Having mobile phones to receive text messages.
- Agrees to participate in the study.
Key exclusion criteria (2 listed)
- Planning to move away during 1 year study period.
- Participating in any kind of oral health education and promotion programs.
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 |
|---|---|---|
| Gain and loss framed mobile text messagesTo assess the effect of message framing on enhancing oral health practices in a group of refugees | Behavioural | Gain-framed messages, Loss-framed message |
Primary outcome
Oral health-related quality of life improvement
Time frame: Immediately after structured oral health session, 6 months and 1 year after baseline
To assess change in OHRQL using OHIP
Oral health practices improvement
Time frame: 6 months and 1 year after baseline
Assess toothbrushing and flossing frequency before and after the education session and reminder mobile messages
Oral hygiene status assesment
Time frame: 6 months and 1 year after baseline
measure the change in plaque index scores among participants
Gingival health assessment
Time frame: 6 months and 1 year after baseline
measure the change in gingival index scores among participants
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 7 Jul 2026.
- Derived from this study: PubMed 42464234Attia D, ElKashlan MK, Saleh SM, Adham MM. Effect of framed mHealth messages on oral hygiene and quality of life among Sudanese refugees in Egypt: a randomized controlled trial. BMC Oral Health. 2026 Jul 17;26(1):1275. doi: 10.1186/s12903-026-09252-z.
- Individual participant dataSharing planned: No. Study protocol and assessment forms.
Related trials for Caries,Dental
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
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.
Mona El Kashlan, Professor study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gain and loss framed mobile text messages in people with Caries,Dental and Plaque, Dental, 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 5 inclusion and 2 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 7 Jul 2026. 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?
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?
Oral health-related quality of life improvement (time frame: Immediately after structured oral health session, 6 months and 1 year after baseline). The study lists 4 primary outcomes in all. 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 NCT06649760, which also lists 1 linked publication.
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 7 Jul 2026.