CariesNCT01710865
Effectiveness of Two Sealant Materials Over 5 Years
A study testing Ultraseal Sealant in people with Caries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 2 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Ultraseal Sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children that are at a high risk of developing caries.
Who cannot join
- Children that already have sealants or do not need them.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evidence Based Effectiveness of Pit and Fissure Sealants Applied By Students and Paediatric Dentists After (Three) Five Years.
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.
Read the 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.
- Conditions
- Caries
- Being tested
- Ultraseal Sealant
- Keywords
- Caries prevention, pit and fissure sealants
- Medical subject headings
- Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultraseal SealantOther
Also called Ultraseal XT Hydro
This is a newly developed hydrophilic sealant material.
Ultraseal SealantOther
Also called Ultraseal XT Plus
This is a previously existing hydrophobic sealant material.
| Study group | Role | What they receive |
|---|---|---|
| Ultraseal Sealant | Experimental | Both Ultraseal XT Hydro and Ultraseal XT Plus will be applied on patients. Receives: Other: Ultraseal Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and every year (baseline to five years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
Why it stopped: withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Sahza Hatibov-Kofman, D.D.S.FRCD, Principal investigator, Division of Orthodontics and Paediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710865
- Sponsor's protocol ID
- 041386
- Status last verified
- Nov 2017
- First submitted
- 24 Jul 2012
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Based Effectiveness of Pit and Fissure Sealants Applied By Students and Paediatric Dentists After (Three) Five Years.
- ClinicalTrials.gov ID
- NCT01710865
- Acronym / sponsor ID
- 041386
- Conditions
- Caries
- Keywords
- Caries prevention, pit and fissure sealants
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- First posted
- 19 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultraseal Sealant | Experimental | Other: Ultraseal SealantBoth Ultraseal XT Hydro and Ultraseal XT Plus will be applied on patients. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children that are at a high risk of developing caries.
Key exclusion criteria (1 listed)
- Children that already have sealants or do not need them.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultraseal SealantAlso: Ultraseal XT HydroThis is a newly developed hydrophilic sealant material. | Other | Ultraseal Sealant |
| Ultraseal SealantAlso: Ultraseal XT PlusThis is a previously existing hydrophobic sealant material. | Other | Ultraseal Sealant |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Sahza Hatibov-Kofman, D.D.S.FRCD principal investigator
Division of Orthodontics and Paediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultraseal Sealant in people with Caries, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in retention of sealants from baseline to five years (time frame: Baseline and every year (baseline to five years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.