NCT01710865

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 19, 2012

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

First QC Date

July 24, 2012

Last Update Submit

November 2, 2017

Conditions

Caries

Keywords

Caries preventionpit and fissure sealants

Outcome Measures

Primary Outcomes (1)

  • Changes in retention of sealants from baseline to five years

    The assessment of the retention of sealants (intact, partially lost, completely lost) will be carried out every year for 5 years.

    Baseline and every year (baseline to five years)

Study Arms (1)

Ultraseal Sealant

EXPERIMENTAL

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

Other: Ultraseal Sealant

Interventions

Ultraseal SealantOTHER

This is a newly developed hydrophilic sealant material.

Also known as: Ultraseal XT Hydro
Ultraseal Sealant

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Children that already have sealants or do not need them.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Clinic at Western University

London, Ontario, N6A2S9, Canada

Location

MeSH Terms

Conditions

Van der Woude syndrome

Interventions

Ultra Seal XT

Study Officials

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

    Division of Orthodontics and Paediatric Dentistry

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2012

First Posted

October 19, 2012

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

CA(1)