NCT03188952

Brief Summary

  • Number of visits \& follow up period: There will be 2 visits and 6-months follow up between 2 visits.
  • Direct benefit of the research to the human volunteer:To get the most appropriate treatment plan .
  • Scientific Value and social benefits:obtain better information quality and support Dentist Discussion making.
  • Expected risk to human subjects:: the ordinary side effects associated with any restorative treatment and no of the study variable has side effect on the patient and in case of any side effect due to the restorative treatment , the participant will directly contact the operator.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

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

June 8, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

July 3, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

June 8, 2017

Last Update Submit

June 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Validity of screening system

    The outcome( Validity) will be measured by measuring Reproducibility of each screening system using Kappa equation .

    an average of 1 year

Study Arms (2)

ICDAS

ACTIVE COMPARATOR

International Caries Detection and Assessment System : Caries assessment system which is used to assess Any carious lesions then they are rated in codes from 0,1,2,3,4,5,6

Diagnostic Test: International Caries Classification and Management System

ICCMS

EXPERIMENTAL

International Caries Classification and Management System Any carious lesions detected are rated in score as the follow:Code 0 = ICDAS 0 Code A = ICDAS 1,2 Code B = ICDAS 3,4 Code C= ICDAS 4,6

Diagnostic Test: International Caries Classification and Management System

Interventions

Caries assessment and management system

Also known as: ICCMS
ICCMSICDAS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Articles published in English
  • Articles published after 2002.
  • ICDAS \& ICCMS
  • Reproducibility

You may not qualify if:

  • In any other languages.
  • Articles published before 2002.
  • Any other clinical evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, +02, Egypt

Location

Study Officials

  • omima Safwat, PHD

    Professor of Conservative Dentistry, Cairo University

    STUDY DIRECTOR
  • Amir Hafez, PHD

    Lecturer of Conservative Dentistry, Cairo University

    STUDY CHAIR

Central Study Contacts

Amr sobhy abd elmounem, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessors will not be blind to intervention/control assessment methods. However it will not be allowed amongst the examiners to exchange any information throughout the entire study period
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 8, 2017

First Posted

June 16, 2017

Study Start

July 3, 2017

Primary Completion

June 1, 2018

Study Completion

June 30, 2018

Last Updated

June 16, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Locations