About this trial
This prospective clinical study aims to evaluate the diagnostic accuracy of intraoral scans (IOS) for the detection of dental plaque and caries. The diagnostic performance of IOS will be compared with current clinical reference standards. For plaque assessment, IOS-based evaluation will be compared with plaque detection using disclosing agents. For caries detection, IOS (including white-light imaging and caries detection features) will be compared with conventional visual inspection and bitewing radiography. Adult patients aged 18 to 70 years will be included.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 18 to 70 years
Not pregnant and not planning pregnant
At least 20 teeth present
Ability to provide informed consent
Disqualifiers
Conditions that prevent proper intraoral examination (e.g., severe gag reflex, limited mouth opening)
patient unable to provide informed consent
Trial population
Adult patients aged 18 to 70 years undergoing intraoral examination in a clinical setting, with at least 20 teeth, who are not pregnant and able to provide informed consent.
Trial design
Cohort
Prospective
Treatments tested in this trial
intraoral scan
Diagnostic testintraoral scanning used for assessment of dental plaque and caries.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic Accuracy of Intraoral Scan for Dental Plaque Detection
Diagnostic accuracy of intraoral scan compared with plaque assessment using disclosing agents.
Secondary outcomes
Agreement Between Intraoral Scan and Reference Standard for Dental Caries Detection
Agreement between intraoral scan assessments and reference standard (visual inspection and bitewing radiography) using kappa statistics.
Sponsors and contacts
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