Clinical Effectiveness of(VistaProof)in Comparison With ICDAS-II & Histological Validation for Detecting Occlusal Caries

Completed

• Conditions: Light Fluorescence Device
• Interventions: Device: vistacam proof; Other: ICDASII; Procedure: fissurotomy

• Registration Number: NCT03940170
• Lead Sponsor: Mohamed samy El-sayed

Brief Summary

a diagnostic accuracy study control trial is to be held to evaluate the Clinical performance of quantitative light fluorescence based device (Vistacam Proof) in comparison with the visual examination and histological validation in detection of initial pits and fissures caries

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-05-04
• Study First Posted: 2019-05-07
• Study Start: 2020-05-01
• Primary Completion: 2021-05-13
• Status Verified: 2021-08
• Study Completion: 2021-08-09
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Patients aged from 15 to 50 years.
• Patient at least has one posterior pits and fissure occlusal caries.
• No gender restriction
• Co-operative patients who signed the informed consent.
• Good general health
• Acceptable oral health

Exclusion Criteria

• Pregnancy.
• Disabilities.
• Systemic disease or severe medical complications.
• Allergic history concerning methacrylate.
• Rampant caries.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
vistacam	vistacam proof	-
Fissurotomy	ICDASII	-
ICDAS II	ICDASII	-
Fissurotomy	fissurotomy	-
Fissurotomy	vistacam proof	-

Primary Outcome Measures

Name	Time	Method
pits and fissure caries	through study completion, an average of 1 year	occlusal pits and fissure caries in posterior teeth non-cavitated

Trial Locations

Locations (1)

The British University in Egypt; 🇪🇬 Cairo, Egypt