Dental CariesNCT07011381
Parental Perception of Oral Health-Related Quality of Life in Sudanese Refugee vs. Egyptian Children
An observational study of Dental Caries and Gingivitis, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This cross-sectional analytical study aims to assess and compare parental perceptions of oral health-related quality of life (OHRQoL) among Sudanese refugee children and Egyptian children aged 6-12 years living in Egypt. The study will include 192 child-parent pairs (96 Sudanese refugees and 96 Egyptians). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Gingivitis, Oral Health
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2025to 20 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Sudanese refugee and Egyptian children aged 6-12 years attending selected schools and community centers in Cairo, Egypt.
Who may be able to join
- Children aged 6-12 years
- Either Sudanese refugee or Egyptian national
- Resident in Cairo for at least 1 year
- Informed consent obtained from parent or legal guardian
Who cannot join
- Systemic health conditions affecting oral health
- Ongoing orthodontic treatment
- Children with special health care needs or developmental disabilities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Kafrelsheikh University, Faculty of Oral and Dental Medicine
Kafr ash Shaykh, Kafr Ash Shaikh/ Elhamrawy, 33511
About this study
Official title: Parental Perception of Oral Health-Related Quality of Life Among Sudanese Refugee Children Compered to Egyptian Children
This cross-sectional analytical study aims to assess and compare parental perceptions of oral health-related quality of life (OHRQoL) among Sudanese refugee children and Egyptian children aged 6-12 years living in Egypt. The study will include 192 child-parent pairs (96 Sudanese refugees and 96 Egyptians). Data will be collected via a validated Arabic questionnaire adapted from the Child Oral Health Impact Profile (COHIP) and clinical oral health examinations using DMFT/dmft indices, Gingival Index, and Plaque Index. The study seeks to identify disparities in oral health, parental awareness, and access to dental care services, thereby informing future community-based interventions and public health policies targeting vulnerable populations such as refugee children.
- Conditions
- Dental Caries, Gingivitis, Oral Health, Refugee Health
- Keywords
- dental caries, gingivitis, oral health, refugee health
- Medical subject headings
- Dental Caries, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sudanese Refugee Children Group | Children aged 6-12 years residing in [location], identified as Sudanese refugees. Participants will undergo clinical oral health assessment and complete a child oral health quality of life questionnaire (COHIP). Parental perception will be documented through structured interviews. | |
| Egyptian Children Group | Children aged 6-12 years residing in [location], identified as native Egyptian citizens. Participants will undergo clinical oral health assessment and complete the same COHIP questionnaire. Parental perception will also be recorded via interviews. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Total Score on the Child Oral Health Impact Profile (COHIP) Questionnaire
Measured using the validated Arabic version of the Child Oral Health Impact Profile (COHIP) questionnaire. Total score and domain-specific subscores (Oral Health, Functional Well-being, Emotional Well-being, School Environment, and Self-image) will be analyzed.
Full name: Child Oral Health Impact Profile (COHIP), Arabic version
Score range: 0 to 140
Higher scores = better oral health-related quality of life
Measured: Baseline (single clinical visit at enrollment)
Secondary outcomes (1)
Clinical Oral Health Status
Includes the DMFT/dmft index (Decayed, Missing, and Filled Teeth), plaque index, and gingival index, assessed by calibrated dental examiners according to WHO guidelines.
Outcome 1 : Mean Decayed, Missing, and Filled Teeth (DMFT/dmft) Index Score
Unit: index score (range 0-28 or appropriate scale)
Outcome 2 : Mean Plaque Index Score
Unit: index score ( 0-3)
Outcome 3 : Mean Gingival Index Score
Unit: index score ( 0-3)
Measured: Baseline (Day 1, clinical oral examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start10 Jun 2025
- Primary completion10 Jul 2025
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHOGI BOREY ELBOSHRA SULIAMAN, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011381
- Sponsor's protocol ID
- KFSIRB200-599
- Status last verified
- Aug 2025
- First submitted
- 9 May 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Perception of Oral Health-Related Quality of Life Among Sudanese Refugee Children Compered to Egyptian Children
- ClinicalTrials.gov ID
- NCT07011381
- Acronym / sponsor ID
- KFSIRB200-599
- Conditions
- Dental Caries, Gingivitis, Oral Health, Refugee Health
- Keywords
- dental caries, gingivitis, oral health, refugee health
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 8 Jun 2025 (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 cross-sectional analytical study aims to assess and compare parental perceptions of oral health-related quality of life (OHRQoL) among Sudanese refugee children and Egyptian children aged 6-12 years living in Egypt. The study will include 192 child-parent pairs (96 Sudanese refugees and 96 Egyptians). Data will be collected via a validated Arabic questionnaire adapted from the Child Oral Health Impact Profile (COHIP) and clinical oral health examinations using DMFT/dmft indices, Gingival Index, and Plaque Index. The study seeks to identify disparities in oral health, parental awareness, and access to dental care services, thereby informing future community-based interventions and public health policies targeting vulnerable populations such as refugee children.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sudanese Refugee Children Group | – | –Children aged 6-12 years residing in [location], identified as Sudanese refugees. Participants will undergo clinical oral health assessment and complete a child oral health quality of life questionnaire (COHIP). Parental perception will be documented through structured interviews. |
| Egyptian Children Group | – | –Children aged 6-12 years residing in [location], identified as native Egyptian citizens. Participants will undergo clinical oral health assessment and complete the same COHIP questionnaire. Parental perception will also be recorded via interviews. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Sudanese refugee and Egyptian children aged 6-12 years attending selected schools and community centers in Cairo, Egypt.
Key inclusion criteria (4 listed)
- Children aged 6-12 years
- Either Sudanese refugee or Egyptian national
- Resident in Cairo for at least 1 year
- Informed consent obtained from parent or legal guardian
Key exclusion criteria (3 listed)
- Systemic health conditions affecting oral health
- Ongoing orthodontic treatment
- Children with special health care needs or developmental disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Total Score on the Child Oral Health Impact Profile (COHIP) Questionnaire
Time frame: Baseline (single clinical visit at enrollment)
Measured using the validated Arabic version of the Child Oral Health Impact Profile (COHIP) questionnaire. Total score and domain-specific subscores (Oral Health, Functional Well-being, Emotional Well-being, School Environment, and Self-image) will be analyzed. Full name: Child Oral Health Impact Profile (COHIP), Arabic version Score range: 0 to 140 Higher scores = better oral health-related quality of life
1 secondary outcome
Clinical Oral Health Status
Time frame: Baseline (Day 1, clinical oral examination)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and Gingivitis, run by Kafrelsheikh 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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 26 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mean Total Score on the Child Oral Health Impact Profile (COHIP) Questionnaire (time frame: Baseline (single clinical visit at enrollment)). 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 26 Aug 2025.