Effectiveness of Two Sealant Materials Over 5 Years

Not Applicable

Withdrawn

• Conditions: Caries
• Interventions: Other: Ultraseal Sealant

• Registration Number: NCT01710865
• Lead Sponsor: Lawson Health Research Institute

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.

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 Timeline

• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-19
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultraseal Sealant	Ultraseal Sealant	Both Ultraseal XT Hydro and Ultraseal XT Plus will be applied on patients.

Primary Outcome Measures

Name	Time	Method
Changes in retention of sealants from baseline to five years	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.

Trial Locations

Locations (1)

Children's Clinic at Western University; 🇨🇦 London, Ontario, Canada