Glass Ionomer CementPhase 4NCT03034837
Effectiveness and Economic Evaluation of Glass Ionomer Material Using as Dental Sealant
A Phase 4 study testing resin sealant and ART sealant in people with Glass Ionomer Cement and Cost-effectiveness, run by Zhengzhou University at 2 sites in China.
Trial summary
Eruption of the first permanent molar is the earliest in our oral cavity, leading to a high occurrence of dental caries in its pits and fissures. Early prevention of pit and fissure caries in this tooth is therefore of great importance for the preservation of a healthy dentition in one's life long time. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Glass Ionomer Cement, Cost-effectiveness, Pit and Fissure Caries (Disorder)
- What is being tested?
- resin sealant and ART sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 329 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2016to Jun 2018
- Phase
- Phase 4
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- generally healthy grade 1-2 school children
- with written parental consent
- with at least 1 sound and fully erupted permanent first molar
Who cannot join
- Can not cooperate with the treatment
- Can not obtain the child's parental consent
Trial locations and contacts
2 sites in 1 country.
China2 sites
Jianxinjie Primary School
Zhengzhou, Henan, 450000
Ruhelu Primary School
Zhengzhou, Henan, 450000
About this study
Official title: Economic Evaluation of ART Sealant in Preventing Pit and Fissure Caries in Permanent First Molars in an Asia Population
Eruption of the first permanent molar is the earliest in our oral cavity, leading to a high occurrence of dental caries in its pits and fissures. Early prevention of pit and fissure caries in this tooth is therefore of great importance for the preservation of a healthy dentition in one's life long time.
It has been shown that sealing the occlusal surface with pit and fissure sealant is a highly effective method to prevent pit and fissure caries. It has also been shown that the performance of sealing pits and fissures by glass ionomer materia l (the high viscosity, classification type 2 GIC material) using finger press method used in the atraumatic restoration method is as significant as that of using the traditional resin sealant material and technique.
The purpose of this study is to evaluate the long-term cost-effectiveness performance of the two sealing materials in the prevention of pits and fissures caries in young permanent molars of schoolchildren in a dental public health program to be held in primary schools. The findings will provide valuable information for decision making on the election of proper material and method for use in dental public program, especially for child population in the rural or social-economically deprived areas.
Read the detailed description
Primary school children will be recruited and cluster randomized into three groups. Baseline dental check-up will be conducted to all the recruited children and dental status will be recorded. Placement of resin sealant or sealant using the glass ionomer material to the eligible permanent first molars or providing of oral health education will be interventions to the three groups respecively according to the group allocation. All the interventions will be provided only once in this study, and the children will be followed for at least 24 months at an six month interval to motor the dental caries of the included permanent first molars. Cost-effectiveness of placement of resin sealant and glass ionomer sealant will be evaluated and reported.
- Being tested
- resin sealant, ART sealant
- 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.
resin sealantDrug
Also called SDI conseal f
Sealing the occlusal surface of the included molars using the market product of SDI conseal f once.
ART sealantDrug
Also called GIC sealant, 3M ESPE KetacTM Molar Easymix" glass ionomer cement
Sealing the occlusal surface of the included molars using the market product of 3M ESPE KetacTM Molar Easymix" glass ionomer cement once.
| Study group | Role | What they receive |
|---|---|---|
| Resin sealant | Active comparator | Sealing pit and fissures of the included permanent first molars using "SDI conseal f" resin sealant material once at the baseline of the study. Receives: Drug: resin sealant |
| ART sealant | Experimental | Sealing pit and fissures of the included permanent first molars using "3M ESPE KetacTM Molar Easymix" glass ionomer cement material once at the baseline of the study. Receives: Drug: ART sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost-effectiveness of sealing
the incrental cost-effectiveness ratio of different sealing material used in this study in preventing pit and fissure caries in the permanent molars.
Measured: 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glass Ionomer CementStudies 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Baoying, Zhengzhou University
- Investigators
- Baoying Liu, PhD, Principal investigator, Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034837
- Sponsor's protocol ID
- 201503121
- Status last verified
- Jul 2019
- First submitted
- 23 Jan 2017
- Last updated
- 8 Jul 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation of ART Sealant in Preventing Pit and Fissure Caries in Permanent First Molars in an Asia Population
- ClinicalTrials.gov ID
- NCT03034837
- Acronym / sponsor ID
- 201503121
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 27 Jan 2017 (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.
Eruption of the first permanent molar is the earliest in our oral cavity, leading to a high occurrence of dental caries in its pits and fissures. Early prevention of pit and fissure caries in this tooth is therefore of great importance for the preservation of a healthy dentition in one's life long time.
It has been shown that sealing the occlusal surface with pit and fissure sealant is a highly effective method to prevent pit and fissure caries. It has also been shown that the performance of sealing pits and fissures by glass ionomer materia l (the high viscosity, classification type 2 GIC material) using finger press method used in the atraumatic restoration method is as significant as that of using the traditional resin sealant material and technique.
The purpose of this study is to evaluate the long-term cost-effectiveness performance of the two sealing materials in the prevention of pits and fissures caries in young permanent molars of schoolchildren in a dental public health program to be held in primary schools. The findings will provide valuable information for decision making on the election of proper material and method for use in dental public program, especially for child population in the rural or social-economically deprived areas.
Detailed description
Primary school children will be recruited and cluster randomized into three groups. Baseline dental check-up will be conducted to all the recruited children and dental status will be recorded. Placement of resin sealant or sealant using the glass ionomer material to the eligible permanent first molars or providing of oral health education will be interventions to the three groups respecively according to the group allocation. All the interventions will be provided only once in this study, and the children will be followed for at least 24 months at an six month interval to motor the dental caries of the included permanent first molars. Cost-effectiveness of placement of resin sealant and glass ionomer sealant will be evaluated and reported.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin sealant | Active comparator | Drug: resin sealantSealing pit and fissures of the included permanent first molars using "SDI conseal f" resin sealant material once at the baseline of the study. |
| ART sealant | Experimental | Drug: ART sealantSealing pit and fissures of the included permanent first molars using "3M ESPE KetacTM Molar Easymix" glass ionomer cement material once at the baseline of the study. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- generally healthy grade 1-2 school children
- with written parental consent
- with at least 1 sound and fully erupted permanent first molar
Key exclusion criteria (2 listed)
- Can not cooperate with the treatment
- Can not obtain the child's parental consent
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 |
|---|---|---|
| resin sealantAlso: SDI conseal fSealing the occlusal surface of the included molars using the market product of SDI conseal f once. | Drug | Resin sealant |
| ART sealantAlso: GIC sealant, 3M ESPE KetacTM Molar Easymix" glass ionomer cementSealing the occlusal surface of the included molars using the market product of 3M ESPE KetacTM Molar Easymix" glass ionomer cement once. | Drug | ART sealant |
Primary outcome
cost-effectiveness of sealing
Time frame: 24-month
the incrental cost-effectiveness ratio of different sealing material used in this study in preventing pit and fissure caries in the permanent molars.
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 8 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Glass Ionomer Cement
Not yet recruiting
Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial)
Dental Caries, Cervical Caries
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
Not yet recruiting
Repair Versus Replacement of Failed Restorations in Primary Teeth
Dental Caries, Restoration Defects
Active, not recruiting
Comparison of Bond Failure Rate of Orthodontic Brackets Bonded With V-Prep and Resin-Modified Glass Ionomer Cement Versus Conventional Acid-Etch Composite Resin
Bracket Failure, Bracket Bonding
Recruiting
Root Coverage Performance of Restorative Materials in Class V Cavities
Gingival Recession, Non-Carious Cervical Lesions (NCCLs)
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.
Baoying Liu, PhD principal investigator
Zhengzhou University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing resin sealant and ART sealant in people with Glass Ionomer Cement and Cost-effectiveness, run by Zhengzhou University at 2 sites in China.
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 3 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 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
cost-effectiveness of sealing (time frame: 24-month). 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 8 Jul 2019.