Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05777057
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-20
First Post:
2023-02-01
Brief Title:
Assessing Accuracy of Kavo Diagnodent
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Comparison Between KAVO DIAGNOdent and Digital Radiography in Occlusal Caries Detection A Diagnostic Accuracy Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the accuracy of kavodiagondent and compare with digital radiograph vista scanthe gold standard is light microscope
Detailed Description:
Extracted teeth with intial caries no cavitationwill be used to detect caries The teeth will be numbered and each of the occlusal surfaces will be measured by DIAGNOdent with a conical probe in accordance with the manufacturers instructions The standard value for each individual tooth will be calibrated before each measurement by measuring in a region of sound tissue The occlusal surfaces will be carefully scanned and measured 3 times when wet and 3 times after they had been wiped with paper tissues and exposed to air for about 2 min in room temperature The maximum value from each measurement will be registered and the mean values of the three data under wet and dry conditions respectively will be calculated After an interval of 2 weeks the procedure will be repeated under identical conditions All occlusal surfaces will be photographed The sites with the highest values will be indicated in the photographs in order to identify the location for the second measurement and for subsequent sectioning for light microscope examination
The teeth will be arranged in pairs and mounted in plaster blocks Reproducible radiographs will be obtained This will be done by digital radiography vista scan sensor The radiographs will be examined by 4 radiologists The observers will be instructed to select one of five ratings to represent his or her level of confidence that a carious lesion was present or not in the occlusal surfaces of the teeth The following scale was used 1 definitely not caries 2 probably not Caries 3 questionable 4 probably caries and 5 definitely caries
After the laser fluorescence measurements had been completed and the digital radiographs had been exposed the teeth will be removed from the blocks and embedded in plastic At the sites indicated in the photographs buccolingual sections approximately 300 µm thick will be taken perpendicular to the occlusal surfaces using a water-cooled saw The slices will then examined under light microscope The lesion depth will be scored on a scale from 0 to 4 where 0 sound 1 enamel caries limited to the outer half of the enamel 2 enamel caries in the inner half of the enamel 3 dentinal caries in the outer half of the dentine and 4 dentinal caries in the inner half of the dentine
The teeth will be arranged in pairs and mounted in plaster blocks Reproducible radiographs will be obtained This will be done by digital radiography vista scan sensor The radiographs will be examined by 4 radiologists The observers will be instructed to select one of five ratings to represent his or her level of confidence that a carious lesion was present or not in the occlusal surfaces of the teeth The following scale was used 1 definitely not caries 2 probably not Caries 3 questionable 4 probably caries and 5 definitely caries
After the laser fluorescence measurements had been completed and the digital radiographs had been exposed the teeth will be removed from the blocks and embedded in plastic At the sites indicated in the photographs buccolingual sections approximately 300 µm thick will be taken perpendicular to the occlusal surfaces using a water-cooled saw The slices will then examined under light microscope The lesion depth will be scored on a scale from 0 to 4 where 0 sound 1 enamel caries limited to the outer half of the enamel 2 enamel caries in the inner half of the enamel 3 dentinal caries in the outer half of the dentine and 4 dentinal caries in the inner half of the dentine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None