Assessing Accuracy of Kavo Diagnodent

Sponsor

Cairo University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05777057

Collaborator

(none)

Enrollment

Location

Arm

4.4

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to evaluate the accuracy of kavodiagondent and compare with digital radiograph (vista scan).the gold standard is light microscope

Condition or Disease	Intervention/Treatment	Phase
Condition	Diagnostic Test: Diagnodent	N/A

Detailed Description

Extracted teeth with intial caries (no cavitation)will 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 manufacturer's 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

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Extracted teeth are radiographed and examined by diagnodent and then sections are examined under light microscopeExtracted teeth are radiographed and examined by diagnodent and then sections are examined under light microscope

Masking:

None (Open Label)

Masking Description:

2 radiologist don't know the results of diagnodent and doctor in lab also don't know the the results of diagnodent and radiograph

Primary Purpose:

Diagnostic

Official Title:

Comparison Between KAVO DIAGNOdent and Digital Radiography in Occlusal Caries Detection (A Diagnostic Accuracy Study)

Actual Study Start Date :

Nov 16, 2022

Actual Primary Completion Date :

Nov 16, 2022

Anticipated Study Completion Date :

Mar 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Extracted teeth Extracted teeth with intial caries without cavitation is examined by diagnodent and digital imaging and then by light microscope	Diagnostic Test: Diagnodent using DIAGNDENT depends on the principle that when 655nm wavelength of Diode laser is irradiated on dental surface, intraoral bacteria metabolites will absorb it and then metabolites emit a red fluorescence. The dental surface will reflect this fluorescence and gives number between 0 and 99 on the screen of the DIAGNdent.

Arm

Intervention/Treatment

Other: Extracted teeth

Extracted teeth with intial caries without cavitation is examined by diagnodent and digital imaging and then by light microscope

Diagnostic Test: Diagnodent

using DIAGNDENT depends on the principle that when 655nm wavelength of Diode laser is irradiated on dental surface, intraoral bacteria metabolites will absorb it and then metabolites emit a red fluorescence. The dental surface will reflect this fluorescence and gives number between 0 and 99 on the screen of the DIAGNdent.

Outcome Measures

Primary Outcome Measures

To detect of occlusal caries [4 months]
Primary Outcome Measure: 1.To detect of occlusal caries To detect occlusal caries.42 teeth with initial non cavitated caries will be examined by kavodiagondent and then radiographed. 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 teeth will be radiographed.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. the light microscope will be used as gold standard.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Extracted posterior teeth Visually intact occlusal surfaces or a variety of occlusal carious lesions, but no obvious cavities
Removal of organic material and stains from the surfaces, the teeth will be immersed in 10% sodium hypochlorite solution for 20 min, followed by rinsing in distilled water for 20 min. The teeth will then stored in saturated thymol solution or formalin.
The teeth will be arranged in pairs and mounted in plaster blocks.

Exclusion Criteria:

Teeth with deep cavity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanaa Mahmoud elsayed	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanaa Mahmoud Elsayed Said, Demonstrator at the Faculty of Dentistry at Misr University for Science and Technology, Cairo University

ClinicalTrials.gov Identifier:

NCT05777057

Other Study ID Numbers:

ORAD 3-3-1

First Posted:

Mar 20, 2023

Last Update Posted:

Mar 20, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Mar 20, 2023