NCT03051594

Reliability of Fluorescent Camera and Caries Detection Dye Versus the Visual Tactile Method

Status unknown NA Last updated 13 February 2017

What this trial tests

NA trial testing fluorescent camera in Dental Caries in 20 participants. Status unknown.

Timeline

3 February 2017

Primary endpoint
1 March 2018

30 March 2018

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	device feasibility
Enrollment	20
Start date	3 February 2017
Primary completion	1 March 2018
Estimated completion	30 March 2018
Sites	1 location across Egypt

Drugs / interventions tested

• fluorescent camera
• caries detector dye
• visual tactile assessment

Conditions studied

• Dental Caries — all drugs for Dental Caries →

Sponsor

Cairo University

Who can join

Eligibility, any sex, with Dental Caries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1. Three dentinal carious lesions will be chosen in this study and will be in the same patient.
2. Using local anaesthesia and rubber dam, the operative field will disinfected with 1% hypochlorite, and the dentine lesions should be exposed with a high-speed diamond bur by removing covering enamel.
3. Before the excavation dentine samples are collected for baseline bacteriological assessment .
4. Excavation will be carried out using new slow speed round burs and hand excavators.
5. The excavation end point of one cavity will be determined using visual tactile method. The two other cavities will be inspected with fluorescent camera or caries detector dye (CDD) methods to determine excavation endpoint respectively.
6. After excavation, dentine samples from the three cavities will be collected using a sterile excavator for the bacteriological assessment.

* Number of visits \& follow up period: all procedures will be done at the same visit and there is no follow up period.

Direct benefit of the research to the human volunteer: to determine the excavation endpoint to ensure complete caries removal and prevent it's recurrence in the future.

Scientific value and social benefits: to reach the best method to determine the excavation endpoint.

Expected risk to the 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.