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

NCT03051594 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-02-13

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

DEVICE

fluorescent camera

used too detect residual caries depending on the bacterial byproducts.

OTHER

caries detector dye

dye used to detect the residual caries.

DIAGNOSTIC_TEST

visual tactile assessment

method usually used to detect the residual caries.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • mohamed riad farid, PHD · Professor of Conservative Dentistry, Cairo university

  • Rasha Ra'faat Abdel Aziz, PHD · Lecturer of Conservative Dentistry, Cairo university

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-03
Primary Completion
2018-03-01
Completion
2018-03-30
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03051594 on ClinicalTrials.gov