Visual ImpairmentNCT07665047
Assessment of Caries Impacts and Experiences in a Visually Impaired Versus Sighted Children Using CARIES-QC/A
An observational study of Visual Impairment, run by Cairo University.
Trial summary
The goal of this observational study is to to compare dental caries impacts and experience among visually impaired and sighted children. The main question it aims to answer is: Among schoolchildren aged 6-14 years, does visual impairment compared to normal sight lead to poorer caries experiences and lower… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Visual Impairment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Aug 2027
- 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 14 years
- All sexes
- Child
Study population: * Visually impaired: Children aged from 6 to 14 years attending Elnor School, Fayoum Governorate. * Sighted children: children of the same age recruited from public schools in the same geographic region
Who may be able to join
- Children's age ranges from 6 to 14 years.
- Apparently healthy children
- Parents' acceptance of their children's participation in the study.
Who cannot join
- Children on long-term medication.
- Parents who refuse to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Caries Impacts and Experiences in a Visually Impaired Versus Sighted Pediatric Population Using a Caries-Specific Quality-of-Life Questionnaire: A Comparative Cross-sectional Study
The goal of this observational study is to to compare dental caries impacts and experience among visually impaired and sighted children. The main question it aims to answer is:
Among schoolchildren aged 6-14 years, does visual impairment compared to normal sight lead to poorer caries experiences and lower caries-related quality of life?
Read the detailed description
This observational study aims to compare the quality of life between \&caries experience visually impaired and sighted children
Visually impaired people may be at a higher risk of developing oral diseases due to various limitations in activities and perception. In accordance with the WHO Global strategy and action plan on oral health 2023-2030, it is necessary to advance research on people with disabilities to identify the limitations and their consequences in receiving dental health as well as in maintaining good oral health.
Our pilot study showed mean CARIES-QC/A scores of 9.7 ± 7.3 for the visually impaired group and 4.1 ± 3.5 for the sighted group. While this points to a large effect size (d = 0.98), pilot data often inflate these numbers. To avoid an underpowered study, we adopted a more conservative, medium effect size (d = 0.5) for our calculations. This requires a minimum of 63 participants per group. To account for potential dropouts or incomplete data, we rounded our final target up to 70 participants per group.
Caries-related quality of life will be assessed as a primary outcome using CARIES-QC, which is administered to participants through an interview. while the secondary outcome, which is Caries Experience, will be assessed using DMF index for permanent dentition and DMF \& def index for mixed dentition Data collected will be saved and tabulated on a computer for backup and finally statistically analyzed.
the finding of this study aims to increase awareness, guide public health programs, reduce dental disease burden, strength school-community partnerships, and promote equity in oral healthcare for visually impaired children.
Practitioners will benefit from from this study by better understanding of the oral health needs of visually impaired children, the development of tailored preventive strategies, and contributions to evidence-based practice in pediatric and special-needs dentistry.
- Conditions
- Visual Impairment
- Keywords
- visually impaired, caries, quality of life
- Medical subject headings
- Vision Disorders
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 |
|---|---|---|
| visually impaired children | Children aged from 6 to 14 years attending Elnor School, Fayoum Governorate. | |
| sighted children | children of the same age recruited from public schools in the same geographic region |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental caries-related quality of Life
Caries Impacts and Experiences Questionnaire for Children ( Caries -QC) It includes 12 questions ( each question have a score 0, 1 or 2) Minimum score : 0 Maximum score : 24 A higher score means a worse outcome
Measured: 2 years
Secondary outcomes (1)
Caries experience score
For permanent teeth, the DMFT index will compute the total number of decayed (D), missing due to caries (M), and filled (F) teeth (scale range: 0 to 32)
For Mixed dentition : Caries experience will be assessed concurrently for both permanent and primary dentition. For permanent teeth, the DMFT index will compute the total number of decayed (D), missing due to caries (M), and filled (F) teeth (scale range: 0 to 32). For primary teeth, the deft index will compute the total number of decayed (d), indicated for extraction due to caries (e), and filled (f) teeth (scale range: 0 to 20). Missing primary teeth are excluded from the 'e' component if exfoliated naturally. Scores for both indices will be recorded during a single clinical examination per participant
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Souty Emad Waheeb, Cairo University
- Investigators
- Nevin Hmaed Gamil Waly, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665047
- Sponsor's protocol ID
- AQ-Pedo-2026
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Caries Impacts and Experiences in a Visually Impaired Versus Sighted Pediatric Population Using a Caries-Specific Quality-of-Life Questionnaire: A Comparative Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07665047
- Acronym / sponsor ID
- AQ-Pedo-2026
- Conditions
- Visual Impairment
- Keywords
- visually impaired, caries, quality of life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Jun 2026 (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.
The goal of this observational study is to to compare dental caries impacts and experience among visually impaired and sighted children. The main question it aims to answer is:
Among schoolchildren aged 6-14 years, does visual impairment compared to normal sight lead to poorer caries experiences and lower caries-related quality of life?
Detailed description
This observational study aims to compare the quality of life between \&caries experience visually impaired and sighted children
Visually impaired people may be at a higher risk of developing oral diseases due to various limitations in activities and perception. In accordance with the WHO Global strategy and action plan on oral health 2023-2030, it is necessary to advance research on people with disabilities to identify the limitations and their consequences in receiving dental health as well as in maintaining good oral health.
Our pilot study showed mean CARIES-QC/A scores of 9.7 ± 7.3 for the visually impaired group and 4.1 ± 3.5 for the sighted group. While this points to a large effect size (d = 0.98), pilot data often inflate these numbers. To avoid an underpowered study, we adopted a more conservative, medium effect size (d = 0.5) for our calculations. This requires a minimum of 63 participants per group. To account for potential dropouts or incomplete data, we rounded our final target up to 70 participants per group.
Caries-related quality of life will be assessed as a primary outcome using CARIES-QC, which is administered to participants through an interview. while the secondary outcome, which is Caries Experience, will be assessed using DMF index for permanent dentition and DMF \& def index for mixed dentition Data collected will be saved and tabulated on a computer for backup and finally statistically analyzed.
the finding of this study aims to increase awareness, guide public health programs, reduce dental disease burden, strength school-community partnerships, and promote equity in oral healthcare for visually impaired children.
Practitioners will benefit from from this study by better understanding of the oral health needs of visually impaired children, the development of tailored preventive strategies, and contributions to evidence-based practice in pediatric and special-needs dentistry.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| visually impaired children | – | –Children aged from 6 to 14 years attending Elnor School, Fayoum Governorate. |
| sighted children | – | –children of the same age recruited from public schools in the same geographic region |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- * Visually impaired: Children aged from 6 to 14 years attending Elnor School, Fayoum Governorate. * Sighted children: children of the same age recruited from public schools in the same geographic region
Key inclusion criteria (3 listed)
- Children's age ranges from 6 to 14 years.
- Apparently healthy children
- Parents' acceptance of their children's participation in the study.
Key exclusion criteria (2 listed)
- Children on long-term medication.
- Parents who refuse to participate in the study
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
Dental caries-related quality of Life
Time frame: 2 years
Caries Impacts and Experiences Questionnaire for Children ( Caries -QC) It includes 12 questions ( each question have a score 0, 1 or 2) Minimum score : 0 Maximum score : 24 A higher score means a worse outcome
1 secondary outcome
Caries experience score
Time frame: 2 years
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 24 Jun 2026.
- 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.
Nevin Hmaed Gamil Waly, professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Impairment, run by Cairo University.
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 3 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: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Souty Emad Waheeb (+201550221011, souty.emad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental caries-related quality of Life (time frame: 2 years). 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 24 Jun 2026.