Assessing Accuracy of Kavo Diagnodent

NCT05777057 | Unknown FDA Device

• 1 other identifier: ORAD 3-3-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Condition

Outcome Measures

Primary Outcomes (1)

• To detect of occlusal caries

  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.

  4 months

Study Arms (1)

Extracted teeth

OTHER

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

Diagnostic Test: Diagnodent

Interventions

Diagnodent DIAGNOSTIC_TEST

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.

Extracted teeth

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Teeth with deep cavity

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hanaa Mahmoud elsayed

Cairo, Egypt

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 2 radiologist don't know the results of diagnodent and doctor in lab also don't know the the results of diagnodent and radiograph
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator at the Faculty of Dentistry at Misr University for Science and Technology

Model Details: Extracted teeth are radiographed and examined by diagnodent and then sections are examined under light microscope

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: March 20, 2023
• Study Start: November 16, 2022
• Primary Completion: November 16, 2022
• Study Completion: March 30, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

EG (1)