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

Sponsor

Sheng-Chao Wang (Other)

Overall Status

Unknown status

CT.gov ID

NCT03077035

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries on Pit and Fissure Surface	Other: glass ionomer sealants Other: resin-based sealant	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Actual Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2017

Anticipated Study Completion Date :

Nov 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: glass ionomer sealant

Other: glass ionomer sealants

Active Comparator: resin-based sealant

Other: resin-based sealant

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 9 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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