Effectiveness of Two Sealant Materials Over 5 Years

November 2, 2017 updated by: Lawson Health Research Institute

Evidence Based Effectiveness of Pit and Fissure Sealants Applied By Students and Paediatric Dentists After (Three) Five Years.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A2S9
        • Children's Clinic at Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultraseal Sealant
Both Ultraseal XT Hydro and Ultraseal XT Plus will be applied on patients.
Other: Ultraseal Sealant
This is a newly developed hydrophilic sealant material.
Other Names:
  • Ultraseal XT Hydro
Other: Ultraseal Sealant
This is a previously existing hydrophobic sealant material.
Other Names:
  • Ultraseal XT Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in retention of sealants from baseline to five years
Time Frame: Baseline and every year (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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Dr. Sahza Hatibov-Kofman, D.D.S.FRCD, Division of Orthodontics and Paediatric Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 24, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (Estimate)

October 19, 2012

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 041386

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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