Evidence Based Effectiveness of Pit and Fissure Sealants Applied By Students and Paediatric Dentists After (Three) Five Years.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Changes in retention of sealants from baseline to five years
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 14 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Ultraseal Sealant
Both Ultraseal XT Hydro and Ultraseal XT Plus will be applied on patients.
Intervention: Ultraseal Sealant (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported