Clinical Assessment of Caries and Dental Plaque Based on Auto-fluorescence Imaging System

January 30, 2017 updated by: Hui Chen

Clinical Detection and Quantification of Caries and Dental Plaque Based on Auto-fluorescence Imaging System: An Observational Study

The purpose of this study was to evaluate the applicability of auto-fluorescence imaging system to detect and quantify caries and dental plaque. Participants were advised to rinse their mouth with distilled water to exclude any chance of fluorescence from food debris. A well trained physicist majored in optical spectroscopy captured auto-fluorescence images of buccal aspects of two maxillary central incisors and occlusal aspects of four first molars from each patient in a dark room. Then they chewed a disclosing agent to assess the Quigley Hein plaque index modified by Turesky of each tooth. Furthermore, participants were also required to brush their teeth for 3min, then International Caries Detection and Assessment System(ICDAS)codes of relevant teeth to evaluate degrees of caries were recorded by an experienced dentist using a mouth mirror and explorer. The Spearman rank correlation coefficient between colorimetric parameters of fluorescence image and the plaque index and ICDAS code were calculated to evaluate the sensitivity and specificity of auto-fluorescence imaging system.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 54 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consisted of 60 patients are from the Affiliated Stomatology Hospital of Medical College, Zhejiang University. They have caries in their mouth and need to be treated by dentists with filling cavity. Two maxillary central incisors and four first molars exist in each patient.

Description

Inclusion Criteria:

Subjects were required to:

  • 1. have two maxillary central incisors and four first molars in mouth;
  • 2. have caries in their mouth or have a high risk to get caries and need to be treated by dentists ;
  • 3. sign informed consent form.

Exclusion Criteria:

  • 1.two incisors and four first molars of participants ever received endodontics treatment;
  • 2. history of antibiotics, mouthwashes, or any periodontal treatment during the last 3 months;
  • 3.with calculus and cementum exposed in tooth cervical;
  • 4. active systemic disease;
  • 5. physical or mental disability;
  • 6. pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auto-fluorescence image assessment
Time Frame: 1 week after image collection
Colorimetric parameters of auto-fluorescence images of buccal aspects of two maxillary central incisors and occlusal aspects of four first molars from each patient were calculated to get the Percentage Plaque Index (PPI). PPI is defined as the ratio between area of dental plaque on teeth and the whole teeth area.
1 week after image collection
The Quigley Hein plaque index modified by Turesky
Time Frame: right after disclosing

After disclosing dental plaque, plaque index was evaluated as following scoring system:0 no plaque;

  1. separate flecks of plaque at the cervical margin of the margin of the tooth;
  2. a thin continuous band of plaque (up to 1 mm) at the cervical margin;
  3. a band of plaque wider than 1 mm but covering less than (1/3)rd of crown;
  4. plaque covering at least (1/3)rd but less than (2/3)rd of the crown;
  5. plaque covering (2/3)rd or more of the crown
right after disclosing
ICDAS scoring results
Time Frame: right after oral detection

After brushing teeth, ICDAS codes were recorded by an experienced dentist using a mouth mirror and explorer:0 sound;

  1. first visual change in enamel;
  2. distinct visual change in enamel;
  3. localized enamel breakdown;
  4. underlying dentine shadow;
  5. distinct cavity with visible dentine;
  6. extensive cavity within visible dentine.
right after oral detection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Hui Chen, Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

January 30, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (Estimate)

January 31, 2017

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • DHZhejiangU1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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