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

NCT03051594 | Unknown DMC FDA Device

• 1 other identifier: oper 603
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Three dentinal carious lesions will be chosen in this study and will be in the same patient.
2. 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. 3.Before the excavation dentine samples are collected for baseline bacteriological assessment .
4. 4.Excavation will be carried out using new slow speed round burs and hand excavators.
5. 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. 6.After excavation, dentine samples from the three cavities will be collected using a sterile excavator for the bacteriological assessment.
7. 7.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

Outcome Measures

Primary Outcomes (1)

• bacterial count

  will be done by Digital colony counter, Agar diffusion test

  an average of 1 year

Study Arms (3)

visual tactile assessment

ACTIVE COMPARATOR

dentine sample collection and then bacterial count by Digital colony counter, Agar diffusion test after visual tactile assessment.

Diagnostic Test: visual tactile assessment

caries detector dye

ACTIVE COMPARATOR

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

fluorescent camera

EXPERIMENTAL

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

Interventions

fluorescent camera DEVICE

used too detect residual caries depending on the bacterial byproducts.

fluorescent camera

caries detector dye OTHER

dye used to detect the residual caries.

caries detector dye

visual tactile assessment DIAGNOSTIC_TEST

method usually used to detect the residual caries.

visual tactile assessment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy.
• Systemic disease or severe medical complications.
• Heavy smoking.
• Xerostomia.
• Lack of compliance.
• Evidence of temporomandibular joint disorders.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mohamed Mohamed sabry Mohamed

Cairo, Nasr City, 11311, Egypt

RECRUITING

Related Publications (1)

• Stoll R, Urban-Klein B, Giacomin P, Loukas A, Jablonski-Momeni A. In vivo assessment of caries excavation with a fluorescence camera compared to direct bacteriological sampling and quantitative analysis using flow cytometry. Lasers Med Sci. 2015 Feb;30(2):843-9. doi: 10.1007/s10103-013-1459-2. Epub 2013 Oct 19.

  PMID: 24142047 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• mohamed riad farid, PHD

  Professor of Conservative Dentistry, Cairo university

  STUDY DIRECTOR

• Rasha Ra'faat Abdel Aziz, PHD

  Lecturer of Conservative Dentistry, Cairo university

  STUDY CHAIR

Central Study Contacts

mohamed mohamed sabry, master

CONTACT

01113564856; mohamed.sabry@dentistry.cu.edu.eg

mohamed mohamed sabry, master

CONTACT

01005475566; Dr.mohamedsabry90@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at conservative department

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 13, 2017
• Study Start: February 3, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 30, 2018
• Last Updated: February 13, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)