Reliability of Secondary Caries Detection Around Composite Restoration Using Light Induced Fluorescence

NCT03558113 | Unknown DMC

• 1 other identifier: CEBD-CU-2018-06-04
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 29 volunteer patients will be assigned in this study. Each patient should have one resin composite restoration. The restoration will be evaluated by two diagnostic methods (D), where D1 represents visual-tactile assessment method (modified USPHS) and D2 represents light induced fluorescence intraoral camera

Conditions

Secondary Caries

Outcome Measures

Primary Outcomes (1)

• reliability and reproducibility of intra oral light fluorescence camera using kappa strength

  in secondary craies diagnosis around composite restorations

  6 months

Study Arms (1)

visual tactile method

OTHER

visual tactile method using the modified USHPS critiria

Diagnostic Test: light induced fluorescence intraoral camera

Interventions

light induced fluorescence intraoral camera DIAGNOSTIC_TEST

intraoral oral light induced fluorescence diagnostic camera

Also known as: soprolife camera

visual tactile method

Eligibility Criteria

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

You may qualify if:

• Patients should be over 18 years of age. Patients should have an acceptable oral hygiene level. Patients must have at least one posterior resin composite restoration

You may not qualify if:

• Patients with a compromised medical history. Severe or active periodontal disease. Heavy bruxism or a traumatic occlusion.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11221, Egypt

Location

Central Study Contacts

Haneen elmoselhy, master

CONTACT

01003778829; noonyelmoselhy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master student

Model Details: Screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients' restorations will be subjected to visual examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. If interested, more detailed evaluations and preparations are made.

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 15, 2018
• Study Start: August 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-06

Locations

EG (1)