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

NCT ID: NCT03077035

Last Updated: 2017-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2017-11-01

Brief Summary

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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

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Conditions

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Dental Caries on Pit and Fissure Surface

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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glass ionomer sealant

Group Type EXPERIMENTAL

glass ionomer sealants

Intervention Type OTHER

resin-based sealant

Group Type ACTIVE_COMPARATOR

resin-based sealant

Intervention Type OTHER

Interventions

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glass ionomer sealants

Intervention Type OTHER

resin-based sealant

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheng-Chao Wang

OTHER

Sponsor Role lead

Responsible Party

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Sheng-Chao Wang

Director, Preventive Dentistry Department, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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School of Stomatology The Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Guo, MM

Role: CONTACT

86-29-84776479

Facility Contacts

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Shengchao Wang, PHD

Role: primary

86-29-84776159

Other Identifiers

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GJ-02

Identifier Type: -

Identifier Source: org_study_id

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