Evaluation of Reliability of the Near-infrared Imaging System (VistaCam iX Proxi) in Comparison With Digital Radiographic Findings and ICDAS-II in Detection of Approximal Carious Lesions.

NCT03923192 | Completed

• 1 other identifier: 2411
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the Clinical performance of the near-infrared imaging system VistaCam iX Proxi in comparison with digital radiographic findings and ICDAS-II in detection of approximal carious lesions.

Conditions

Proximal Dental Caries

Outcome Measures

Primary Outcomes (1)

• dental caries

  hidden proximal caries

  through study completion, an average of 1 year

Study Arms (1)

ICDAS II

OTHER

Visual tactile examination based on ICDASII scoring system

Device: Vistacam; Radiation: Bitewing radiograph

Interventions

Vistacam DEVICE

device for early proximal caries detection

ICDAS II

Bitewing radiograph RADIATION

radiograph for proximal caries detection

ICDAS II

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged from 18 to 40 years.
• No gender restriction.
• Patients should have an acceptable oral hygiene level.
• Patients must have at least one posterior proximal caries

You may not qualify if:

• Patients with a compromised medical history.
• Severe or active periodontal disease.
• Heavy bruxism or a traumatic occlusion.
• Acute or chronic dental infection.
• Pregnant or breastfeeding women.
• Patients with posterior restorations on molars or premolars

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

The British University in Egypt

Cairo, Other, 223453, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: screening of the Patients who join the Conservative Dentistry Department clinic will be done until the target population is achieved. The Patients' teeth will be subjected to visual examination and diagnosis using dental charts. once the patient is eligible to be included in this study, they will be contacted by the research investigator who will explain the study and identify the patient interests .If the patient show interest ,further clarification and discussing wil be held .

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: May 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

EG (1)