Back to resultsUsing ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression
Primary Purpose
Dental Caries on Pit and Fissure Surface
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
glass ionomer sealants
resin-based sealant
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries on Pit and Fissure Surface focused on measuring ICDAS, DIAGNOdent, glass ionomer sealant, resin-based sealant, pit and fissure sealants, effectiveness of preventing caries
Eligibility Criteria
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
Sites / Locations
- School of Stomatology The Fourth Military Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
glass ionomer sealant
resin-based sealant
Arm Description
Outcomes
Primary Outcome Measures
Change in Decayed Surfaces (DS) of Different Fissure Sealants
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.
Change in Repaired Sealants by the baseline ICDAS
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.
Change in DIAGNOdent Score
The peak value of DIAGNOdent was recorded after repeating it 3 times in the baseline and 3 follow-ups
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03077035
Brief Title
Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
October 1, 2017 (Anticipated)
Study Completion Date
November 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sheng-Chao Wang
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries on Pit and Fissure Surface
Keywords
ICDAS, DIAGNOdent, glass ionomer sealant, resin-based sealant, pit and fissure sealants, effectiveness of preventing caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
glass ionomer sealant
Arm Type
Experimental
Arm Title
resin-based sealant
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
glass ionomer sealants
Intervention Type
Other
Intervention Name(s)
resin-based sealant
Primary Outcome Measure Information:
Title
Change in Decayed Surfaces (DS) of Different Fissure Sealants
Description
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.
Time Frame
Baseline, 6 months, 12 months and 24 months
Title
Change in Repaired Sealants by the baseline ICDAS
Description
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.
Time Frame
6 months, 12 months and 24 months
Title
Change in DIAGNOdent Score
Description
The peak value of DIAGNOdent was recorded after repeating it 3 times in the baseline and 3 follow-ups
Time Frame
Baseline, 6 months, 12 months and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Guo, MM
Phone
86-29-84776479
Email
lucyjing@126.com
Facility Information:
Facility Name
School of Stomatology The Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengchao Wang, PHD
Phone
86-29-84776159
Email
wangshengchao@fmmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression
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