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

Dental Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03038412
• Other study ID #: DHZhejiangU1
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 30, 2017
• Last updated: January 30, 2017
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2017
• Source: The Dental Hospital of Zhejiang University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 54 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries (Diagnosis)
• Dental Plaque
• Optical Imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hui Chen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week after image collection
Primary	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	right after disclosing
Primary	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.	right after oral detection