Reliability of Fluorescent Camera and Caries Detection Dye Versus the Visual Tactile Method
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|ClinicalTrials.gov Identifier: NCT03051594|
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
- Three dentinal carious lesions will be chosen in this study and will be in the same patient.
- 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.
- Before the excavation dentine samples are collected for baseline bacteriological assessment .
- Excavation will be carried out using new slow speed round burs and hand excavators.
- 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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Device: fluorescent camera Other: caries detector dye Diagnostic Test: visual tactile assessment||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The side to which interventions or control is assigned to will be recorded and all records of all patients will be kept with the main supervisor . The operator will not be blinded as the difference in application protocol of the restorative materials prohibited blinding of the operator; however, the patient, Statisticians and Outcome assessors will be blinded to the material assignment|
|Primary Purpose:||Device Feasibility|
|Official Title:||Reliability of Fluorescent Camera and Caries Detection Dye Versus the Visual Tactile Method in Determining Caries Excavation Endpoint Using Microbiological Assessment (Randomized Clinical Trial)|
|Actual Study Start Date :||February 3, 2017|
|Estimated Primary Completion Date :||March 1, 2018|
|Estimated Study Completion Date :||March 30, 2018|
Active Comparator: visual tactile assessment
dentine sample collection and then bacterial count by Digital colony counter, Agar diffusion test after visual tactile assessment.
Diagnostic Test: visual tactile assessment
method usually used to detect the residual caries.
Active Comparator: caries detector dye
dentine sample collection and then bacterial count by Digital colony counter, Agar diffusion test after after using caries detector dye to determine the excavation endpoint.
Other: caries detector dye
dye used to detect the residual caries.
Experimental: fluorescent camera
dentine sample collection and then bacterial count by Digital colony counter, Agar diffusion test after after using fluorescent camera to determine the excavation endpoint.
Device: fluorescent camera
used too detect residual caries depending on the bacterial byproducts.
- bacterial count [ Time Frame: an average of 1 year ]will be done by Digital colony counter, Agar diffusion test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051594
|Contact: mohamed mohamed sabry, firstname.lastname@example.org|
|Contact: mohamed mohamed sabry, master||01005475566||Dr.email@example.com|
|Mohamed Mohamed sabry Mohamed||Recruiting|
|Cairo, Nasr City, Egypt, 11311|
|Contact: Mohamed Mohamed Sabry Mohamed, master 01113564856 firstname.lastname@example.org|
|Contact: Mohamed Mohamed Sabry Mohamed, master 01005475566 Dr.email@example.com|
|Principal Investigator: Mohamed Mohamed Sabry Mohamed, master|
|Study Director:||mohamed riad farid, PHD||Professor of Conservative Dentistry, Cairo university|
|Study Chair:||Rasha Ra'faat Abdel Aziz, PHD||Lecturer of Conservative Dentistry, Cairo university|