NCT03224962

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

July 13, 2017

Last Update Submit

July 24, 2017

Conditions

Caries

Keywords

pit and fissure caries

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

diagnostic tool

Light induced fluorescence camera Caries detection dye. visual assessment method (ICDAS criteria)

Device: fluorescence camera

Interventions

fluorescence cameraDEVICE

drug - diagnostic test

Also known as: Caries detection dye., visual assessment method (ICDAS criteria)
diagnostic tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult populations suffering from occlusal caries.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Van der Woude syndrome

Study Officials

  • Mona I Riad, Professor

    Conservative Dentistry Department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

shimaa M Zenhom Abd El Rahman, B A

CONTACT

(002)01001036094shimaa-maher@dentistry.cu.edu.eg

amir hafez, lecturer

CONTACT

(002)01100001278amir.hafez@dentistry.cu.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

July 13, 2017

First Posted

July 21, 2017

Study Start

August 1, 2017

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

July 25, 2017

Record last verified: 2017-07