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

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

Study Locations

    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • School of Stomatology The Fourth Military Medical University
        • Contact:

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

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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