Fissure SealantNCT03235960
Efficacy of Glass-ionomer Fissure Sealants
An observational study of Fissure Sealant and Glass-ionomer Cement, run by Association of Paediatric and Preventive Dentists of Serbia at 1 site in Serbia.
Trial summary
Despite numerous techniques for enamel protection, occlusal caries still remains a problem. Sealing pits and fissures is considered to be an effective way of preventing caries development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Fissure Sealant, Glass-ionomer Cement, Permanent Molar
- What is being tested?
- glass-ionomer fissure sealant
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Jan 2004to 1 Aug 2017
- Phase
- Observational
- 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 5 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children who appeared for a regular dental examination
Who may be able to join
- at least one recently erupted permanent molar with sound pits and fissures
- healthy patients
- possibility to perform a dental treatment
- willing to participate in the study
Who cannot join
- teeth with an obvious cavity, with a restoration or a sealant completely or partially presented in the fissure system
- medically compromised patients
- non cooperative patients
- not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Glass-ionomer Fissure Sealants
Despite numerous techniques for enamel protection, occlusal caries still remains a problem. Sealing pits and fissures is considered to be an effective way of preventing caries development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.
Read the detailed description
Despite numerous techniques for enamel protection, such as topical fluorides, calcium phosphate-based remineralization systems, xylitol, etc., occlusal caries still remains a problem. A carious lesion occurs in pits and fissures of occlusal surfaces primarily due to their specific anatomy, which is considered to be an ideal site for the retention of bacteria and food remnants rendering mechanical means of debridement inaccessible. Sealing pits and fissures is considered to be an effective way of preventing caries development. Today, there is a wide spectrum of available sealing materials. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. During last decades, glass-ionomer cements of different physical and chemical properties were used for pits and fissure sealing which probably contributed to variances in their clinical efficacy. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.
- Conditions
- Fissure Sealant, Glass-ionomer Cement, Permanent Molar
- Being tested
- glass-ionomer fissure sealant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glass-ionomer fissure sealantDevice
The encapsulated glass-ionomer cement for fissure protection was applied onto the selected permanent molar according to the manufacturer's instruction
What is being measured
The primary outcome is the main question the study is designed to answer.
absence of caries
absence of caries on sealed tooth surfaces
Measured: every 12 months during 13 years
retention of sealant
complete or partial retention
Measured: every 12 months during 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Jan 2004
- Primary completion1 Aug 2017 (estimated)
- Study completion1 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fissure SealantStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association of Paediatric and Preventive Dentists of Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dejan Markovic, Association of Paediatric and Preventive Dentists of Serbia
- Investigators
- Dejan Markovic, PhD, Principal investigator, University of Belgrade, School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235960
- Sponsor's protocol ID
- 001-04
- Status last verified
- Jul 2017
- First submitted
- 18 Jul 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Glass-ionomer Fissure Sealants
- ClinicalTrials.gov ID
- NCT03235960
- Acronym / sponsor ID
- 001-04
- Conditions
- Fissure Sealant, Glass-ionomer Cement, Permanent Molar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Association of Paediatric and Preventive Dentists of SerbiaUniversity, hospital or other
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 1 Aug 2017 (estimated)
- Study completion
- 1 Aug 2017 (estimated)
- First posted
- 1 Aug 2017 (actual)
- 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.
Despite numerous techniques for enamel protection, occlusal caries still remains a problem. Sealing pits and fissures is considered to be an effective way of preventing caries development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.
Detailed description
Despite numerous techniques for enamel protection, such as topical fluorides, calcium phosphate-based remineralization systems, xylitol, etc., occlusal caries still remains a problem. A carious lesion occurs in pits and fissures of occlusal surfaces primarily due to their specific anatomy, which is considered to be an ideal site for the retention of bacteria and food remnants rendering mechanical means of debridement inaccessible. Sealing pits and fissures is considered to be an effective way of preventing caries development. Today, there is a wide spectrum of available sealing materials. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. During last decades, glass-ionomer cements of different physical and chemical properties were used for pits and fissure sealing which probably contributed to variances in their clinical efficacy. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children who appeared for a regular dental examination
Key inclusion criteria (4 listed)
- at least one recently erupted permanent molar with sound pits and fissures
- healthy patients
- possibility to perform a dental treatment
- willing to participate in the study
Key exclusion criteria (4 listed)
- teeth with an obvious cavity, with a restoration or a sealant completely or partially presented in the fissure system
- medically compromised patients
- non cooperative patients
- not willing to participate in the study
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 |
|---|---|---|
| glass-ionomer fissure sealantThe encapsulated glass-ionomer cement for fissure protection was applied onto the selected permanent molar according to the manufacturer's instruction | Device | – |
Primary outcome
absence of caries
Time frame: every 12 months during 13 years
absence of caries on sealed tooth surfaces
retention of sealant
Time frame: every 12 months during 13 years
complete or partial retention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Fissure Sealant
Active, not recruiting
The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars
Dental Caries, Fissure Sealant
Enrolling by invitation
Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH).
Molar Incisor Hypomineralization, Fissure Sealant
Not yet recruiting
Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing
Pit and Fissure Sealant Retention, Dental Caries
RecruitingPhase 1
COES: Curing Order Effects on Sealants
Dental Sealant, Sealant Retention
RecruitingObservational study
Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth
Dental Enamel, Dental Enamel Hypomineralization
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.
Dejan Markovic, PhD principal investigator
University of Belgrade, School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fissure Sealant and Glass-ionomer Cement, run by Association of Paediatric and Preventive Dentists of Serbia at 1 site in Serbia.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 Aug 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 Serbia. 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?
Results are not available in the source record.
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?
absence of caries (time frame: every 12 months during 13 years). The study lists 2 primary outcomes in all. 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 1 Aug 2017.