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

Dental Caries on Pit and Fissure Surface Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03077035
• Other study ID #: GJ-02
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2017
• Last updated: March 19, 2017
• Start date: October 1, 2015
• Est. completion date: November 1, 2017

Study information

• Verified date: March 2017
• Source: Fourth Military Medical University
• Contact: Jing Guo, MM
• Phone: 86-29-84776479
• Email: lucyjing[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries on Pit and Fissure Surface

Intervention

Other:
• glass ionomer sealants

• resin-based sealant

Locations

Country	Name	City	State
China	School of Stomatology The Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Sheng-Chao Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Decayed Surfaces (DS) of Different Fissure Sealants	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
Primary	Change in Repaired Sealants by the baseline ICDAS	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
Primary	Change in DIAGNOdent Score	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