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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
Sponsor:
Information provided by (Responsible Party):
mohamed mohamed sabry mohamed, Cairo University

Brief Summary:
  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.


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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. bacterial count [ Time Frame: an average of 1 year ]
    will be done by Digital colony counter, Agar diffusion test



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients with at least three carious lesions .
  2. Males or Females.
  3. Good oral hygiene.
  4. Co-operative patients approving the trial.

Exclusion Criteria:

  1. Pregnancy.
  2. Systemic disease or severe medical complications.
  3. Heavy smoking.
  4. Xerostomia.
  5. Lack of compliance.
  6. Evidence of temporomandibular joint disorders.

Information from the National Library of Medicine

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


Contacts
Contact: mohamed mohamed sabry, master 01113564856 mohamed.sabry@dentistry.cu.edu.eg
Contact: mohamed mohamed sabry, master 01005475566 Dr.mohamedsabry90@yahoo.com

Locations
Egypt
Mohamed Mohamed sabry Mohamed Recruiting
Cairo, Nasr City, Egypt, 11311
Contact: Mohamed Mohamed Sabry Mohamed, master    01113564856    mohamed.sabry@dentistry.cu.edu.eg   
Contact: Mohamed Mohamed Sabry Mohamed, master    01005475566    Dr.mohamedsabry90@yahoo.com   
Principal Investigator: Mohamed Mohamed Sabry Mohamed, master         
Sponsors and Collaborators
Cairo University
Investigators
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

Publications:
Responsible Party: mohamed mohamed sabry mohamed, Resident at conservative department, Cairo University
ClinicalTrials.gov Identifier: NCT03051594     History of Changes
Other Study ID Numbers: oper 603
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publishing the data at egyptian dental journal

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases