NCT04438252

Brief Summary

The aim of this study is to evaluate the Clinical performance of alternating current impedance spectroscopy (CarieScan PRO) in comparison with digital radiograph and ICDAS-II in detection of occlusal carious lesions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

8 months

First QC Date

June 15, 2020

Last Update Submit

June 17, 2020

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Dental Caries

    primary occlusal caries

    slow study completion in average of 1 year

Study Arms (2)

Cariescan pro

EXPERIMENTAL

device for early caries detection

Device: CariScan ProRadiation: Digital Radiograpgy

ICDAS II

EXPERIMENTAL

Index for caries detection

Diagnostic Test: ICDAS II

Interventions

ICDAS IIDIAGNOSTIC_TEST

Index for caries detection

ICDAS II
CariScan ProDEVICE

Device for early caries detection

Cariescan pro
Digital RadiograpgyRADIATION

Device for digital x-ray imaging

Cariescan pro

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Posterior teeth with dark shadow on occlusal surface.
  • Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
  • Intact contact with opposing teeth.
  • Teeth with no previous restorations in other surfaces.

You may not qualify if:

  • Periapical pathology or signs of pulpal pathology.
  • Tooth hypersensitivity.
  • Possible prosthodontic restoration of teeth.
  • Heavy occlusion and occlusal contacts or history of bruxism.
  • Severe periodontal affection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Of Dentistry

Cairo, 11553, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Olfat ElSayed Hassanien, Doctor

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 18, 2020

Study Start

September 1, 2020

Primary Completion

May 1, 2021

Study Completion

September 1, 2021

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations

EG(1)