Effectiveness of Two Sealant Materials Over 5 Years

This study is not yet open for participant recruitment.

Verified October 2012 by Lawson Health Research Institute

Sponsor:

Information provided by (Responsible Party):

Sahza Kofman, Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT01710865

First received: July 24, 2012

Last updated: October 18, 2012

Last verified: October 2012

History of Changes

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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Tooth Decay

U.S. FDA Resources

Further study details as provided by 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) ] [ Designated as safety issue: No ]
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

Ages Eligible for Study:	2 Years to 14 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Sahza Kofman, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT01710865 History of Changes
Other Study ID Numbers:	041386
Study First Received:	July 24, 2012
Last Updated:	October 18, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Lawson Health Research Institute:

Caries prevention
pit and fissure sealants

ClinicalTrials.gov processed this record on May 23, 2013

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