VIPPSTAR-G1 Digital Early Intervention for Visual Impairment
NCT07717671
Blindness, Blindness, Cortical
Leuven, Belgium
View Trial DetailsNCT Number: NCT07665047
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?
Trial opening soon.
Get Notified6 year–14 year
All sexes
Observational
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Contact information is provided by the study sponsor or research team.
Cairo University
Other
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
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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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