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Effectiveness of Two Sealant Materials Over 5 Years

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01710865
Enrollment
0
Registered
2012-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries

Keywords

Caries prevention, pit and fissure sealants

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.

Interventions

OTHERUltraseal Sealant

This is a newly developed hydrophilic sealant material.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in retention of sealants from baseline to five yearsBaseline 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026