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Effectiveness of Two Sealant Materials Over 5 Years

NCT ID: NCT01710865

Last Updated: 2017-11-06

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to assess the effectiveness of a new hydrophilic sealant (Ultraseal XT Hydro) compared to the previously existing hydrophobic sealant materials (Ultraseal XT Plus) which requires prime and dry to dry the tooth surface.

Detailed Description

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The new hydrophobic sealant material eliminates the step of prime and drying the tooth which prevents from over drying the tooth surface and decreases chair time, which is important when working with children. The null hypothesis is that there is no difference between the materials. The alternate hypothesis is that the Ultraseal XT Hydro is a better material.

Conditions

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Caries

Keywords

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Caries prevention pit and fissure sealants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ultraseal Sealant

Both Ultraseal XT Hydro and Ultraseal XT Plus will be applied on patients.

Group Type EXPERIMENTAL

Ultraseal Sealant

Intervention Type OTHER

This is a newly developed hydrophilic sealant material.

Ultraseal Sealant

Intervention Type OTHER

This is a previously existing hydrophobic sealant material.

Interventions

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Ultraseal Sealant

This is a newly developed hydrophilic sealant material.

Intervention Type OTHER

Ultraseal Sealant

This is a previously existing hydrophobic sealant material.

Intervention Type OTHER

Other Intervention Names

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Ultraseal XT Hydro Ultraseal XT Plus

Eligibility Criteria

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Inclusion Criteria

* Children that are at a high risk of developing caries.

Exclusion Criteria

* Children that already have sealants or do not need them.
Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Sahza Hatibov-Kofman, D.D.S.FRCD

Role: PRINCIPAL_INVESTIGATOR

Division of Orthodontics and Paediatric Dentistry

Locations

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Children's Clinic at Western University

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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041386

Identifier Type: -

Identifier Source: org_study_id