Dental CariesPhase 1NCT02659917
Performance of Glass-ionomer Cements: 2-year Follow-up
A Phase 1 study testing Glass ionomer, Glass ionomer cement and -Glass ionomer- in people with Dental Caries, run by Fernanda Miori Pascon.
Trial summary
The purpose of this randomized clinical trial was evaluate the performance of two conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative treatment in high caries risk children. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Glass ionomer, Glass ionomer cement and -Glass ionomer-
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Aug 2010
- Phase
- Phase 1
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Volunteers that having at least two permanent first molars of opposite sides of the mouth, erupted in the oral cavity, caries-free and high-risk disease (presence of white spots, history of caries, plaque in smooth surfaces and gingivitis);
- Children who had one or two bilateral matched pairs of carious deciduous molars that required either class I or class II restorations.
Who cannot join
- Children who did not meet the minimum requirements for the achievement of sealants or parents / guardians did not agree to participate;
- No history of spontaneous pulpal pain.
About this study
Official title: Performance of Glass-ionomer Cements in the Pit and Fissure Sealing and Atraumatic Restorative Treatment: a Randomized 2-year Clinical Trial
The purpose of this randomized clinical trial was evaluate the performance of two conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative treatment in high caries risk children.
Read the detailed description
Sealants were applied on sound permanent first molars by "press finger technique" and carious deciduous molars that required either class I or class II restorations were restored according to manufacturers' recommendations in order to caries prevention and control.
- Conditions
- Dental Caries
- Being tested
- Glass ionomer, Glass ionomer cement, -Glass ionomer-, -Glass ionomer cement-
- Keywords
- glass-ionomer cement, atraumatic restorative treatment, pit and fissure sealants
- Medical subject headings
- Dental Caries, Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass ionomerOther
Application of preventive agent
Glass ionomer cementOther
Application of preventive agent
-Glass ionomer-Other
Atraumatic Restorative Treatment
-Glass ionomer cement-Other
Atraumatic Restorative Treatment
| Study group | Role | What they receive |
|---|---|---|
| Ketac Molar® (3M/ESPE) - Glass ionomer | Active comparator | Pit and fissure sealing using conventional glass-ionomer cement Receives: Other: Glass ionomer |
| Maxxion® (FGM) - Glass ionomer cement | Experimental | Pit and fissure sealing using conventional glass-ionomer cement Receives: Other: Glass ionomer cement |
| Ketac Molar® (3M/ESPE) - Glass ionomer - | Active comparator | Restoration using conventional glass-ionomer cement Receives: Other: -Glass ionomer- |
| Maxxion® (FGM) - Glass ionomer cement - | Experimental | Restoration using conventional glass-ionomer cement Receives: Other: -Glass ionomer cement- |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of the teeth with glass-ionomer cement retention and prevention of caries.
Criteria established by Frencken et al. (1998) was used.
Measured: 6-month
Number of the teeth with good restoration and caries absence.
Criteria established by Frencken et al. (1998) was used.
Measured: 6-month
Secondary outcomes (1)
Frequency of loss of the sealing material and prevention of caries.
Criteria established by Frencken et al. (1998) was used.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startAug 2008
- Primary completionFeb 2009
- Study completionAug 2010
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fernanda Miori Pascon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fernanda Miori Pascon, University of Campinas, Brazil
- Investigators
- Raquel V Rodrigues, PhD Student, Principal investigator, Piracicaba Dental School - University of CampinasAna Carolina G Luciano, DDS, Principal investigator, Piracicaba Dental School - University of CampinasKelly MS Moreira, MS Student, Principal investigator, Piracicaba Dental School - University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659917
- Sponsor's protocol ID
- 3
- Status last verified
- Jan 2016
- First submitted
- 12 Jan 2016
- Last updated
- 21 Jan 2016
- 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 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Glass-ionomer Cements in the Pit and Fissure Sealing and Atraumatic Restorative Treatment: a Randomized 2-year Clinical Trial
- ClinicalTrials.gov ID
- NCT02659917
- Acronym / sponsor ID
- 3
- Conditions
- Dental Caries
- Keywords
- glass-ionomer cement, atraumatic restorative treatment, pit and fissure sealants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Fernanda Miori PasconUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Jan 2016 (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 randomized clinical trial was evaluate the performance of two conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative treatment in high caries risk children.
Detailed description
Sealants were applied on sound permanent first molars by "press finger technique" and carious deciduous molars that required either class I or class II restorations were restored according to manufacturers' recommendations in order to caries prevention and control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ketac Molar® (3M/ESPE) - Glass ionomer | Active comparator | Other: Glass ionomerPit and fissure sealing using conventional glass-ionomer cement |
| Maxxion® (FGM) - Glass ionomer cement | Experimental | Other: Glass ionomer cementPit and fissure sealing using conventional glass-ionomer cement |
| Ketac Molar® (3M/ESPE) - Glass ionomer - | Active comparator | Other: -Glass ionomer-Restoration using conventional glass-ionomer cement |
| Maxxion® (FGM) - Glass ionomer cement - | Experimental | Other: -Glass ionomer cement-Restoration using conventional glass-ionomer cement |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Volunteers that having at least two permanent first molars of opposite sides of the mouth, erupted in the oral cavity, caries-free and high-risk disease (presence of white spots, history of caries, plaque in smooth surfaces and gingivitis);
- Children who had one or two bilateral matched pairs of carious deciduous molars that required either class I or class II restorations.
Key exclusion criteria (2 listed)
- Children who did not meet the minimum requirements for the achievement of sealants or parents / guardians did not agree to participate;
- No history of spontaneous pulpal pain.
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 ionomerApplication of preventive agent | Other | Ketac Molar® (3M/ESPE) - Glass ionomer |
| Glass ionomer cementApplication of preventive agent | Other | Maxxion® (FGM) - Glass ionomer cement |
| -Glass ionomer-Atraumatic Restorative Treatment | Other | Ketac Molar® (3M/ESPE) - Glass ionomer - |
| -Glass ionomer cement-Atraumatic Restorative Treatment | Other | Maxxion® (FGM) - Glass ionomer cement - |
Primary outcome
Number of the teeth with glass-ionomer cement retention and prevention of caries.
Time frame: 6-month
Criteria established by Frencken et al. (1998) was used.
Number of the teeth with good restoration and caries absence.
Time frame: 6-month
Criteria established by Frencken et al. (1998) was used.
1 secondary outcome
Frequency of loss of the sealing material and prevention of caries.
Time frame: 6-month
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 21 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Raquel V Rodrigues, PhD Student principal investigator
Piracicaba Dental School - University of Campinas
Ana Carolina G Luciano, DDS principal investigator
Piracicaba Dental School - University of Campinas
Kelly MS Moreira, MS Student principal investigator
Piracicaba Dental School - University of Campinas
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glass ionomer, Glass ionomer cement and -Glass ionomer- in people with Dental Caries, run by Fernanda Miori Pascon.
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 2 inclusion and 2 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 21 Jan 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of the teeth with glass-ionomer cement retention and prevention of caries. (time frame: 6-month). 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 21 Jan 2016.