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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03077035
Enrollment
300
Registered
2017-03-10
Start date
2015-10-01
Completion date
2017-11-01
Last updated
2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries on Pit and Fissure Surface

Keywords

ICDAS, DIAGNOdent, glass ionomer sealant, resin-based sealant, pit and fissure sealants, effectiveness of preventing caries

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.

Interventions

OTHERglass ionomer sealants

Sponsors

Sheng-Chao Wang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
7 Years to 9 Years
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

Exclusion criteria

* They were allergic to the constituents in pit and fissure sealants

Design outcomes

Primary

MeasureTime frameDescription
Change in DIAGNOdent ScoreBaseline, 6 months, 12 months and 24 monthsThe peak value of DIAGNOdent was recorded after repeating it 3 times in the baseline and 3 follow-ups
Change in Decayed Surfaces (DS) of Different Fissure SealantsBaseline, 6 months, 12 months and 24 monthsCount 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 ICDAS6 months, 12 months and 24 monthsEvaluation 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.

Countries

China

Contacts

Primary ContactJing Guo, MM
lucyjing@126.com86-29-84776479

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026