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NCT Number: NCT07665047

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

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?

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Caries experience score

    Time frame: 2 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Souty Emad Waheeb

CONTACT

[email protected]

+201550221011

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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