Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Typical duration for not_applicable
1 active site
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
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
March 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedMarch 21, 2017
March 1, 2017
2 years
February 23, 2017
March 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Baseline, 6 months, 12 months and 24 months
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.
6 months, 12 months and 24 months
Change in DIAGNOdent Score
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
Study Arms (2)
glass ionomer sealant
EXPERIMENTALresin-based sealant
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- They were allergic to the constituents in pit and fissure sealants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheng-Chao Wanglead
Study Sites (1)
School of Stomatology The Fourth Military Medical University
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Preventive Dentistry Department, Clinical Professor
Study Record Dates
First Submitted
February 23, 2017
First Posted
March 10, 2017
Study Start
October 1, 2015
Primary Completion
October 1, 2017
Study Completion
November 1, 2017
Last Updated
March 21, 2017
Record last verified: 2017-03