- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03077035
Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression
March 19, 2017 updated by: Sheng-Chao Wang
The study was to monitor effectiveness of glass ionomer sealant and resin-based sealant in ICDAS, and to evaluat the correlation between ICDAS and DIAGNOdent over 24 months.
Over 200 8-year-old children with at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4 were placed glass ionomer sealant and resin-based sealant split-mouthed randomly, and examined with ICDAS and DIAGNOdent before sealents placement and 6, 12 and 24 months after.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jing Guo, MM
- Phone Number: 86-29-84776479
- Email: lucyjing@126.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- School of Stomatology The Fourth Military Medical University
-
Contact:
- Shengchao Wang, PHD
- Phone Number: 86-29-84776159
- Email: wangshengchao@fmmu.edu.cn
-
-
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
7 years to 9 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects provided written informed consent;
- They were 7 to 9 years old;
- They have at least 2 permanent molar with the International Caries Detection and Assessment System (ICDAS) scores 0-4;
- They were generally heallthy
Exclusion Criteria:
- They were allergic to the constituents in pit and fissure sealants
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: glass ionomer sealant
|
|
Active Comparator: resin-based sealant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Decayed Surfaces (DS) of Different Fissure Sealants
Time Frame: Baseline, 6 months, 12 months and 24 months
|
Count of DS in different ICDAS cut-off( including D1-6S, D1-2S, D3-6S, D4-6S and D5-6S) in the baseline and 6-month, 12-month and 24-month follow-up.
|
Baseline, 6 months, 12 months and 24 months
|
Change in Repaired Sealants by the baseline ICDAS
Time Frame: 6 months, 12 months and 24 months
|
Evaluation the numbers of tooth surface in which the fissure sealants were in the status partially retained or completely lost, and ICDAS score were increasing from the baseline to the 3 follow-ups.
|
6 months, 12 months and 24 months
|
Change in DIAGNOdent Score
Time Frame: Baseline, 6 months, 12 months and 24 months
|
The peak value of DIAGNOdent was recorded after repeating it 3 times in the baseline and 3 follow-ups
|
Baseline, 6 months, 12 months and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 1, 2015
Primary Completion (Anticipated)
October 1, 2017
Study Completion (Anticipated)
November 1, 2017
Study Registration Dates
First Submitted
February 23, 2017
First Submitted That Met QC Criteria
March 6, 2017
First Posted (Actual)
March 10, 2017
Study Record Updates
Last Update Posted (Actual)
March 21, 2017
Last Update Submitted That Met QC Criteria
March 19, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GJ-02
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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