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

Not Applicable

• Conditions: Dental Caries on Pit and Fissure Surface
• Interventions: Other: glass ionomer sealants; Other: resin-based sealant

• Registration Number: NCT03077035
• Lead Sponsor: Sheng-Chao Wang

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2017-02-23
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-10
• Last Update Submitted: 2017-03-19
• Last Update Posted: 2017-03-21
• Primary Completion: 2017-10-01
• Study Completion: 2017-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glass ionomer sealant	glass ionomer sealants	-
resin-based sealant	resin-based sealant	-

Primary Outcome Measures

Name	Time	Method
Change in Decayed Surfaces (DS) of Different Fissure Sealants	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.
Change in Repaired Sealants by the baseline ICDAS	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.
Change in DIAGNOdent Score	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

Trial Locations

Locations (1)

School of Stomatology The Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China