NCT03188952

Validity of ICDAS Versus ICCMS

Status unknown NA Last updated 16 June 2017

What this trial tests

NA trial testing International Caries Classification and Management System in Caries Assessment in 40 participants. Status unknown.

Timeline

3 July 2017

Primary endpoint
1 June 2018

30 June 2018

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	40
Start date	3 July 2017
Primary completion	1 June 2018
Estimated completion	30 June 2018
Sites	1 location across Egypt

Drugs / interventions tested

• International Caries Classification and Management System

Conditions studied

• Caries Assessment — all drugs for Caries Assessment →

Sponsor

Cairo University

Who can join

18 and older, any sex, with Caries Assessment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1. A total of 40 volunteer patients will be assigned in this study.
2. All patients will be randomly selected with variable caries risks .
3. For each patient The Examiner will use Two screening methods used in caries detection , where D1 represents ICDAS index and D2 represents ICCMS index which are used by each examiner for each patient.
4. Each examiner will record the dental findings using the visual- tactile assessment method .The visual-tactile assessment method includes the use of mirror, probe under good illumination condition
5. After full caries assessment in the 1st visit , All patients will receive full treatment and oral hygiene control .
6. After 6-months follow up re-assessment of same patients will be done by same Examiners .
7. The data of each examiner will be collected, and then the repeat-ability and the reproducibility of each method as well as the inter- and intra-operator agreement will be evaluated using the kappa statistics

* 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.