Reliability of Fluorescent Camera in Diagnosis of Occlusa... | NCT03224962

Studies
Reliability of Fluorescent Camera in Diagnosis of Occlusal Carious Lesion

NCT03224962

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jul 25, 2017Actual

Enrollment

43Estimated

Phase

Not provided

Conditions

Caries

Interventions

fluorescence camera

Countries

Not provided

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

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2017Estimated

Primary Completion Date

Dec 2017Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Jul 13, 2017

First Submission Date that Met QC Criteria

Jul 19, 2017

First Posted Date

Jul 21, 2017Actual

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

Jul 24, 2017

Last Update Posted Date

Jul 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will be conducted to compare the diagnostic predictive values of a light induced fluorescence camera and Caries detection dye versus visual assessment method in identification of occlusal carious lesion.

Detailed Description

A total of 43 volunteer patients will be assigned in this study. Each patient must have at least two occlusal carious lesions. Each lesion will be evaluated by three diagnostic methods (D), where D1 represents light induced fluorescence camera, D2 represents Caries detection dye. And D3 represents visual assessment method (ICDAS criteria)

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

43Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
diagnostic tool		Light induced fluorescence camera Caries detection dye. visual assessment method (ICDAS criteria)	Device: fluorescence camera

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fluorescence camera	Device	drug - diagnostic test	diagnostic tool

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reliability and level of agreement between operators for all diagnostic methods.	It will be assessed using reliability & reproducibility by kappa strength measuring unit	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients should be over 18 Years old
Patient should have good oral hygiene and general health
patients With at least 2 non-cavitated first and/or second molar teeth in each quadrant of maxilla or mandible

Exclusion Criteria:

Known allergy to any component of the dyes used.
Patients having caries at proximal, buccal, lingual surface.
Previously placed sealants or restorations.
Bruxism or malocclusion

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult populations suffering from occlusal caries.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
shimaa M Zenhom Abd El Rahman, B A	Contact	(002)01001036094		shimaa-maher@dentistry.cu.edu.eg
amir hafez, lecturer	Contact	(002)01100001278		amir.hafez@dentistry.cu.edu.eg

Overall Officials

Name	Affiliation	Role
Mona I Riad, Professor	Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.	Principal Investigator

Locations

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
C536528	Van der Woude syndrome

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided