Dental CariesPhase 2NCT02589743
Randomized Clinical Trial of Occlusal Sealant
A Phase 2 study testing Sealant and Adhesive and Sealant in people with Dental Caries, run by University of Campinas, Brazil.
Trial summary
This study assessed long-term impact of tooth Eruption Stages (ES) on sealant retention on occlusal surfaces previously coated with intermediary bonding layer and it determined caries incidence outcome evolved. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Sealant and Adhesive and Sealant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Jun 2005
- Phase
- Phase 2
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Four caries-free erupted first molar permanent teeth; no systemic diseases and no dental material allergies.
Who cannot join
- Carious or absence first molar permanent teeth.
About this study
Official title: Impact of the Intermediary Layer on Sealant Retention: A Randomized 24-month Clinical Trial
This study assessed long-term impact of tooth Eruption Stages (ES) on sealant retention on occlusal surfaces previously coated with intermediary bonding layer and it determined caries incidence outcome evolved. The treatment were (sealant/technique): Fluroshield; Helioseal Clear Chroma; Single Bond and Fluroshield; Excite and Helioseal Clear Chroma.
Read the detailed description
The greatest risk of sealant failure occurs soon after tooth eruption, when contamination with saliva and gingival fluid is almost inevitable. The use of an intermediate bonding layer between humidity contaminated enamel and sealant can improve bond strength, reduces microleakage, and enhances resin flow into fissures. The benefit of primer and adhesive layer beneath the sealant seems to be based on a combination of moisture-chasing effects of the hydrophilic primer, increased flow dispersion imparted by the less viscous primer and adhesive and increased flexibility of the combined and polymerized primer/adhesive/resin complex once reaction is complete.
- Conditions
- Dental Caries
- Being tested
- Sealant, Adhesive and Sealant
- Keywords
- clinical trial, pit and fissure sealants, tooth eruption, retention, adhesive system, intermediary layer
- Medical subject headings
- Dental Caries, Van der Woude syndrome, Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SealantDevice
Application of preventive agent
Adhesive and SealantDevice
Application of preventive agent and technique for control moisture
| Study group | Role | What they receive |
|---|---|---|
| Fluroshield - F (Sealant) | Active comparator | Pit and fissure sealing using only sealant Receives: Device: Sealant |
| Single Bond and F (Adhesive and Sealant) | Experimental | Pit and fissure sealing using adhesive and sealant Receives: Device: Adhesive and Sealant |
| Helioseal Clear Chroma - H (Sealant) | Active comparator | Pit and fissure sealing using only sealant Receives: Device: Sealant |
| Excite and H (Adhesive and Sealant) | Experimental | Pit and fissure sealing using adhesive and sealant Receives: Device: Adhesive and Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealant retention and prevention of dental caries assessed by defined clinical scoring system
Clinical scoring system: adapted criteria proposed by Feigal et al. (2000)
Measured: 6-mouth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startApr 2003
- Primary completionJun 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Profa. Dra. Regina Maria Puppin Rontani, University of Campinas, Brazil
- Investigators
- Kamila Kantovitz, Phd, Principal investigator, Piracicaba Dental Scholl - University of CampinasKelly Moreira, DDS, Principal investigator, Piracicaba Dental Scholl - University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589743
- Sponsor's protocol ID
- 1
- Status last verified
- Oct 2015
- First submitted
- 17 Oct 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Intermediary Layer on Sealant Retention: A Randomized 24-month Clinical Trial
- ClinicalTrials.gov ID
- NCT02589743
- Acronym / sponsor ID
- 1
- Conditions
- Dental Caries
- Keywords
- clinical trial, pit and fissure sealants, tooth eruption, retention, adhesive system, intermediary layer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Apr 2003
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 28 Oct 2015 (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.
This study assessed long-term impact of tooth Eruption Stages (ES) on sealant retention on occlusal surfaces previously coated with intermediary bonding layer and it determined caries incidence outcome evolved. The treatment were (sealant/technique): Fluroshield; Helioseal Clear Chroma; Single Bond and Fluroshield; Excite and Helioseal Clear Chroma.
Detailed description
The greatest risk of sealant failure occurs soon after tooth eruption, when contamination with saliva and gingival fluid is almost inevitable. The use of an intermediate bonding layer between humidity contaminated enamel and sealant can improve bond strength, reduces microleakage, and enhances resin flow into fissures. The benefit of primer and adhesive layer beneath the sealant seems to be based on a combination of moisture-chasing effects of the hydrophilic primer, increased flow dispersion imparted by the less viscous primer and adhesive and increased flexibility of the combined and polymerized primer/adhesive/resin complex once reaction is complete.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fluroshield - F (Sealant) | Active comparator | Device: SealantPit and fissure sealing using only sealant |
| Single Bond and F (Adhesive and Sealant) | Experimental | Device: Adhesive and SealantPit and fissure sealing using adhesive and sealant |
| Helioseal Clear Chroma - H (Sealant) | Active comparator | Device: SealantPit and fissure sealing using only sealant |
| Excite and H (Adhesive and Sealant) | Experimental | Device: Adhesive and SealantPit and fissure sealing using adhesive and sealant |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Four caries-free erupted first molar permanent teeth; no systemic diseases and no dental material allergies.
Key exclusion criteria (1 listed)
- Carious or absence first molar permanent teeth.
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 |
|---|---|---|
| SealantApplication of preventive agent | Device | Fluroshield - F (Sealant), Helioseal Clear Chroma - H (Sealant) |
| Adhesive and SealantApplication of preventive agent and technique for control moisture | Device | Excite and H (Adhesive and Sealant), Single Bond and F (Adhesive and Sealant) |
Primary outcome
Sealant retention and prevention of dental caries assessed by defined clinical scoring system
Time frame: 6-mouth
Clinical scoring system: adapted criteria proposed by Feigal et al. (2000)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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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.
Kamila Kantovitz, Phd principal investigator
Piracicaba Dental Scholl - University of Campinas
Kelly Moreira, DDS principal investigator
Piracicaba Dental Scholl - University of Campinas
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sealant and Adhesive and Sealant in people with Dental Caries, run by University of Campinas, Brazil.
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: finished, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sealant retention and prevention of dental caries assessed by defined clinical scoring system (time frame: 6-mouth). 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 28 Oct 2015.