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Effectiveness of Two Sealant Materials Over 5 Years

This study is not yet open for participant recruitment.
Verified October 2012 by Sahza Kofman, Lawson Health Research Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01710865
First Posted: October 19, 2012
Last Update Posted: October 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sahza Kofman, Lawson Health Research Institute
  Purpose
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.

Condition Intervention
Caries Other: Ultraseal Sealant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evidence Based Effectiveness of Pit and Fissure Sealants Applied By Students and Paediatric Dentists After (Three) Five Years.

Further study details as provided by Sahza Kofman, Lawson Health Research Institute:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Ultraseal XT Hydro
Other: Ultraseal Sealant
This is a previously existing hydrophobic sealant material.
Other Name: Ultraseal XT Plus

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children that already have sealants or do not need them.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01710865


Contacts
Contact: Dr. Sahza Hatibov-Kofman, D.D.S.,FRCD 5196612111 ext 86131 sahza.kofman@schulich.uwo.ca

Locations
Canada, Ontario
Children's Clinic at Western University Not yet recruiting
London, Ontario, Canada, N6A2S9
Contact: Dr. Sahza Hatibov-Kofman, D.D.S.FRCD    (519) 661-2111 ext 86131    sahza.kofman@schulich.uwo.ca   
Principal Investigator: Dr. Sahza Hatibov-Kofman Hatibov-Kofman, D.D.S.FRCD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Dr. Sahza Hatibov-Kofman, D.D.S.FRCD Division of Orthodontics and Paediatric Dentistry
  More Information

Responsible Party: Sahza Kofman, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01710865     History of Changes
Other Study ID Numbers: 041386
First Submitted: July 24, 2012
First Posted: October 19, 2012
Last Update Posted: October 19, 2012
Last Verified: October 2012

Keywords provided by Sahza Kofman, Lawson Health Research Institute:
Caries prevention
pit and fissure sealants