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

NCT03038412 — Unknown, 60 participants, Hui Chen

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

Registry	NCT03038412
Status	Unknown
Study type	Observational
Enrollment	60 (Estimated)
Sponsor	Hui Chen (Other)
Conditions	Dental Caries (Diagnosis), Dental Plaque, Optical Imaging
Dates	start 2016-05-01, primary completion 2017-05-01 (estimated), completion 2017-09-01 (estimated), first posted 2017-01-31, last updated 2017-01-31

-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. 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.

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+Outcome measures

Primary outcomes

Auto-fluorescence image assessment [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 [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 [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.

+Eligibility

Sex: All, ages: 18 Years to 54 Years, accepts healthy volunteers

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.

+Investigators

Hui Chen, Study chair, Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University