Caries; Initial Clinical Trial
Official title:
Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II in Detection of Incipient White Spot Lesions: An In-vivo Evaluation
NCT number | NCT05127356 |
Other study ID # | Diagnodent |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2022 |
Est. completion date | May 5, 2022 |
Verified date | May 2022 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
There is a paradigm shift in conservative dentistry by substituting the surgical model with the medical model of treatment. Early detection of initial carious lesions will aid in clinical decision making during management ; either no care advised, preventive care advised or operative care advised. According to recent systematic reviews meticulous visual examination using ICDAS II presented a substantial level of reproducibility and accuracy for assessment of carious lesions and was considered the reference for clinical visual assessment . However, visual examination is subjective and is highly dependent on the dentist's skills and experience, with high specificity and low sensitivity. New devices have been developed to detect and quantify incipient demineralization. Besides visual detection systems, laser fluorescence assessment can be considered a suitable method. In vitro data suggested that the visual examination and fluorescence method have similar accuracy to detect initial carious lesions.
Status | Completed |
Enrollment | 193 |
Est. completion date | May 5, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: - Non cavitated white spot lesions. - Patient compliance Exclusion Criteria: - Cavitated lesions. - Medically compromised patients. - Enrollment in another clinical trials. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Cairo University | Cairo | El Manial |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy | Assessing the validity of both methods in detecting initial carious lesions in terms of sensitivity and specificity. | Immediate (cross-sectional) |
Status | Clinical Trial | Phase | |
---|---|---|---|
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