Dental Caries (Diagnosis)NCT03038412
Clinical Assessment of Caries and Dental Plaque Based on Auto-fluorescence Imaging System
An observational study of Dental Caries (Diagnosis) and Dental Plaque, run by Hui Chen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries (Diagnosis), Dental Plaque, Optical Imaging
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Dental Caries (Diagnosis), Dental Plaque, Optical Imaging
- Medical subject headings
- Dental Caries, Disease, Dental Plaque
What is being measured
The primary outcome is the main question the study is designed to answer.
Auto-fluorescence image assessment
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.
Measured: 1 week after image collection
The Quigley Hein plaque index modified by Turesky
After disclosing dental plaque, plaque index was evaluated as following scoring system:0 no plaque;
- separate flecks of plaque at the cervical margin of the margin of the tooth;
- a thin continuous band of plaque (up to 1 mm) at the cervical margin;
- a band of plaque wider than 1 mm but covering less than (1/3)rd of crown;
- plaque covering at least (1/3)rd but less than (2/3)rd of the crown;
- plaque covering (2/3)rd or more of the crown
Measured: right after disclosing
ICDAS scoring results
After brushing teeth, ICDAS codes were recorded by an experienced dentist using a mouth mirror and explorer:0 sound；
- first visual change in enamel;
- distinct visual change in enamel;
- localized enamel breakdown;
- underlying dentine shadow;
- distinct cavity with visible dentine;
- extensive cavity within visible dentine.
Measured: right after oral detection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hui Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui Chen, The Dental Hospital of Zhejiang University School of Medicine
- Investigators
- Hui Chen, Study chair, Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038412
- Sponsor's protocol ID
- DHZhejiangU1
- Status last verified
- Jan 2017
- First submitted
- 30 Jan 2017
- Last updated
- 31 Jan 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Detection and Quantification of Caries and Dental Plaque Based on Auto-fluorescence Imaging System: An Observational Study
- ClinicalTrials.gov ID
- NCT03038412
- Acronym / sponsor ID
- DHZhejiangU1
- Conditions
- Dental Caries (Diagnosis), Dental Plaque, Optical Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hui ChenUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- May 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Chen study chair
Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries (Diagnosis) and Dental Plaque, run by Hui Chen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auto-fluorescence image assessment (time frame: 1 week after image collection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.