Effectiveness of Two Sealant Materials Over 5 Years

Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01710865
• Other study ID #: 041386
• Status: Withdrawn
• Phase: N/A
• First received: July 24, 2012
• Last updated: November 2, 2017

Study information

• Verified date: November 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Caries

Intervention

Other:
• Ultraseal Sealant
This is a newly developed hydrophilic sealant material.
• Ultraseal Sealant
This is a previously existing hydrophobic sealant material.

Locations

Country	Name	City	State
Canada	Children's Clinic at Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)