NCT03038412

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

January 30, 2017

Last Update Submit

January 30, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • The Quigley Hein plaque index modified by Turesky

    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

    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

Eligibility Criteria

Age18 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Subjects were required to:
  • \. have two maxillary central incisors and four first molars in mouth;
  • \. have caries in their mouth or have a high risk to get caries and need to be treated by dentists ;
  • \. sign informed consent form.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental CariesDiseaseDental Plaque

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDental Deposits

Study Officials

  • Hui Chen

    Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2017

First Posted

January 31, 2017

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

September 1, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01