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Not yet recruitingNCT07665047Updated Jun 24, 2026

Assessment of Caries Impacts and Experiences in a Visually Impaired Versus Sighted Children Using CARIES-QC/A

An observational study in Visual Impairment, sponsored by Cairo University. Not yet recruiting. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
140
Ages
6 Years to 14 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Visual Impairment

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Keywords

  • visually impaired
  • caries
  • quality of life
03

In context

Vision Disorders

360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.

This study's planned enrollment of 140 is above the median of 126 across 97 observational studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 14 Years
Sexes eligible
All
Sampling method
Non-probability sample

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

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.

Inclusion criteria

  • Children's age ranges from 6 to 14 years.
  • Apparently healthy children
  • Parents' acceptance of their children's participation in the study.

Exclusion criteria

Exclusion Criteria:

  • Children on long-term medication.
  • Parents who refuse to participate in the study
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
140 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07665047
Lead sponsor
Cairo University
Responsible party
Souty Emad Waheeb (Principle investigator, Cairo University) — Principal investigator
First posted
Jun 24, 2026
Start date
Aug 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Aug 2027 (estimated)
Last update
Jun 24, 2026

Study contacts

Souty Emad Waheeb
Contact
souty.emad@dentistry.cu.edu.eg
+201550221011
Nevin Hmaed Gamil Waly, professor
study director · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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