Clinical Effectiveness of(VistaProof)in Comparison With I... | NCT03940170

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

NCT03940170

Sponsor

Mohamed samy El-sayed

Status

Completed

Last Update Posted

Aug 19, 2021Actual

Enrollment

24Actual

Phase

Not provided

Conditions

Light Fluorescence Device

Interventions

vistacam proof
ICDASII
fissurotomy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Actual

Primary Completion Date

May 13, 2021Actual

Completion Date

Aug 9, 2021Actual

First Submitted Date

Apr 25, 2019

First Submission Date that Met QC Criteria

May 4, 2019

First Posted Date

May 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2021

Last Update Posted Date

Aug 19, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vistacam			Device: vistacam proof
ICDAS II			Other: ICDASII
Fissurotomy			Device: vistacam proof Other: ICDASII Procedure: fissurotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vistacam proof	Device	Light fluorescence device	Fissurotomy vistacam

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Egyptian population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The British University in Egypt		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided