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Using ICDAS II and KaVo DIAGNOdent Pen Detecting Tooth Pit and Fissure Level Incipent Caries Progression

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ClinicalTrials.gov Identifier: NCT03077035
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Sheng-Chao Wang, Fourth Military Medical University

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.

Condition or disease Intervention/treatment Phase
Dental Caries on Pit and Fissure Surface Other: glass ionomer sealants Other: resin-based sealant Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Actual Study Start Date : October 1, 2015
Estimated Primary Completion Date : October 1, 2017
Estimated Study Completion Date : November 1, 2017

Arm Intervention/treatment
Experimental: glass ionomer sealant Other: glass ionomer sealants
Active Comparator: resin-based sealant Other: resin-based sealant



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



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Ages Eligible for Study:   7 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077035


Contacts
Contact: Jing Guo, MM 86-29-84776479 lucyjing@126.com

Locations
China, Shaanxi
School of Stomatology The Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Shengchao Wang, PHD    86-29-84776159    wangshengchao@fmmu.edu.cn   
Sponsors and Collaborators
Sheng-Chao Wang

Responsible Party: Sheng-Chao Wang, Director, Preventive Dentistry Department, Clinical Professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT03077035     History of Changes
Other Study ID Numbers: GJ-02
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Keywords provided by Sheng-Chao Wang, Fourth Military Medical University:
ICDAS
DIAGNOdent
glass ionomer sealant
resin-based sealant
pit and fissure sealants
effectiveness of preventing caries

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases