- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03038412
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
Status
Unknown
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;
|
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;
|
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
Additional Relevant MeSH Terms
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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