Fissure SealantNCT04854720
Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars
A study testing Fuji® II LC CAPSULE, Clinpro™ XT Varnish and Beautifil Flow in people with Fissure Sealant, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the clinical retention rates, marginal adaptation, marginal discoloration and secondary caries formation of two different types of resin-modified glass ionomers (Fuji® II LC; Clinpro™ XT Varnish) and giomer-containing fissure sealant materials (Beautifil Flow) with glass… Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Fissure Sealant
- What is being tested?
- Fuji® II LC CAPSULE, Clinpro™ XT Varnish and Beautifil Flow
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2019to 11 Jan 2021
- 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who have two newly erupted non-carious mandibular permanent first molars that fissure sealant is indicated,
- Newly erupted first permanent molars show scores of 0 (Sound tooth surface)-1(First visual change in enamel) according to ICDAS II,
- Newly erupted first permanent molars show scores between 0-13 by using DIAGNOdent device,
- Children who haven't any systemic disease that prevents the application,
- Cooperative children who allowed the clinical applications.
Who cannot join
- Teeth with proximal and initial caries,
- Teeth with applied fissure sealant,
- Teeth with developmental defects such as hypoplasia and restorations,
- Non-cooperative children who don't allow the clinical applications,
- Children and parents who denied the participation in the follow-up appointments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars: A Randomized Controlled Clinical Trial
The aim of this study is to compare the clinical retention rates, marginal adaptation, marginal discoloration and secondary caries formation of two different types of resin-modified glass ionomers (Fuji® II LC; Clinpro™ XT Varnish) and giomer-containing fissure sealant materials (Beautifil Flow) with glass ionomer-containing fissure sealant material (Fuji Triage®) used on newly erupted non-carious first permanent molars as a fissure sealant.
The study included 384 teeth belonging to 182 children, aged between 5 to 9 years old, who have two newly erupted mandibular permanent first molars.
Read the detailed description
Firstly, patients were randomly allocated to three main groups: Group 1; Fuji II LC/Fuji Triage (Control) (62 patients), Group 2; Clinpro XT Varnish/Fuji Triage (Control) (60 patients), Group 3; Beautifil Flow/Fuji Triage (Control) (60 patients). After clinical applications, all samples were evaluated in terms of retention, marginal adaptation, marginal discoloration and secondary caries formation using modified USPHS criteria in 6th, 12th and 18th months. Also samples were evaluated in terms of remineralization effect using the laser fluorescence method. Evaluations on occlusal and buccal surfaces were performed separately.
- Conditions
- Fissure Sealant
- Being tested
- Fuji® II LC CAPSULE, Clinpro™ XT Varnish, Beautifil Flow, Fuji Triage® CAPSULE
- Keywords
- Conventional glass ionomer, fissure sealant, giomer, laser fluorescence, newly erupted teeth, resin modified glass ionomer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuji® II LC CAPSULEDevice
Also called Fuji® II LC CAPSULE, GC Corporation, Tokyo, Japan
Fuji® II LC is a resin modified glass ionomer contained, fluoride releasing and light-cured material. Since the product is tolerant to moisture and saliva, it's used for fissure sealant of newly erupted teeth.
Test 1 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.The tooth surface was rinsed with water and dried. Thereafter, Fuji® II LC was applied to the pits and fissures on the tooth surface using a brush. Then, the varnish was applied and cured according to the manufacturer's instructions.
Clinpro™ XT VarnishDevice
Also called Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USA
Clinpro™ XT Varnish is a resin modified glass ionomer containing, fluoride-releasing, light-cured varnish. Since the product is tolerant to moisture and saliva, it is used for fissure sealant of newly erupted teeth. The product can be recharged with fluoride using fluoride-containing products.
Test 2 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 35% phosphoric acid was applied to all surfaces of the tooth for 15 seconds.Then the tooth surface was rinsed with water and dried. Thereafter, Clinpro™ XT Varnish was applied in compliance with the manufacturers' instructions.
Beautifil FlowDevice
Also called Beautifil Flow, Shofu, Kyoto, Japan
Beautiful Flow is a Giomer contained, fluoride releasing and light cured material. The product contains pre-reacted glass ionomer particles (PRG). It is a high water resistant material. It is used for fissure sealant.
Test 3 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 7% phosphoric acid was applied to all surfaces of the tooth for 10 seconds. Then the tooth surface was rinsed with water and dried. Afterwards, a two-stage self-etch adhesive system was applied. Thereafter, Beautiful Flow was applied in compliance with the manufacturers' instructions.
Fuji Triage® CAPSULEDevice
Also called Fuji Triage® CAPSULE, GC Corporation, Tokyo, Japan
Fuji Triage® is a new generation glass ionomer containing with low viscosity, high fluoride content and light curing materials. Since the product is tolerant of moisture and saliva, it is used for fissure sealant of newly erupted teeth.
Control newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.Then the tooth surface was rinsed with water and dried. Thereafter,Fuji Triage® was applied to the pits and fissures on the tooth surface using a brush. Thereafter, the varnish was applied and cured according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Fuji II LC-Fuji Triage) | Experimental | In Group 1, newly erupted mandibular permanent first molars were sealed with resin-modified glass ionomers containing fissure sealant material (Fuji® II LC, GC Corporation, Tokyo, Japan) (test 1). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control). Receives: Device: Fuji® II LC CAPSULE; Device: Fuji Triage® CAPSULE |
| Group 2 (Clinpro XT Varnish-Fuji Triage) | Experimental | In Group 2, newly erupted mandibular permanent first molars were sealed with resin-modified glass ionomers containing fissure sealant material (Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USA) (test 2). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control). Receives: Device: Clinpro™ XT Varnish; Device: Fuji Triage® CAPSULE |
| Group 3 (Beautiful Flow- Fuji Triage) | Experimental | In Group 3, newly erupted mandibular permanent first molars were sealed with Giomer containing fissure sealant material (Beautifil Flow, Shofu, Kyoto, Japan) (test 3). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control). Receives: Device: Beautifil Flow; Device: Fuji Triage® CAPSULE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars.
The primary outcome of the study was the assessment of clinical retention rates at 18th months.
Measured: 18 months after the clinical applications
The assessment of marginal adaptation rates of fissure sealants applied to newly erupted permanent first molars.
The primary outcome of the study was the assessment of marginal adaptation rates at 18th months.
Measured: 18 months after the clinical applications
The assessment of marginal discoloration rates of fissure sealants applied to newly erupted permanent first molars.
The primary outcome of the study was the assessment of marginal discoloration rates at 18th months.
Measured: 18 months after the clinical applications
The assessment of secondary caries rates of fissure sealants applied to newly erupted permanent first molars.
The primary outcome of the study was the assessment of secondary caries rates at 18th months.
Measured: 18 months after the clinical applications
Secondary outcomes (1)
The assessment of remineralization capacity using DIAGNOdent device
The secondary outcome of the study was the assessment of remineralization capacity using DIAGNOdent, at 18th months.
Measured: 18 months after the clinical applications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start10 Mar 2019
- Primary completion16 Nov 2020
- Study completion11 Jan 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled, three-arm parallel, single-blinded, split-mouth clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve AKCAY, Izmir Katip Celebi University
- Investigators
- Merve Akcay, assoc. prof., Study chair, Izmir Katip Celebi Uni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854720
- Sponsor's protocol ID
- 2018-TDU-DİŞF-0050
- Status last verified
- May 2021
- First submitted
- 18 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04854720
- Acronym / sponsor ID
- 2018-TDU-DİŞF-0050
- Conditions
- Fissure Sealant
- Keywords
- Conventional glass ionomer, fissure sealant, giomer, laser fluorescence, newly erupted teeth, resin modified glass ionomer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 22 Apr 2021 (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.
The aim of this study is to compare the clinical retention rates, marginal adaptation, marginal discoloration and secondary caries formation of two different types of resin-modified glass ionomers (Fuji® II LC; Clinpro™ XT Varnish) and giomer-containing fissure sealant materials (Beautifil Flow) with glass ionomer-containing fissure sealant material (Fuji Triage®) used on newly erupted non-carious first permanent molars as a fissure sealant.
The study included 384 teeth belonging to 182 children, aged between 5 to 9 years old, who have two newly erupted mandibular permanent first molars.
Detailed description
Firstly, patients were randomly allocated to three main groups: Group 1; Fuji II LC/Fuji Triage (Control) (62 patients), Group 2; Clinpro XT Varnish/Fuji Triage (Control) (60 patients), Group 3; Beautifil Flow/Fuji Triage (Control) (60 patients). After clinical applications, all samples were evaluated in terms of retention, marginal adaptation, marginal discoloration and secondary caries formation using modified USPHS criteria in 6th, 12th and 18th months. Also samples were evaluated in terms of remineralization effect using the laser fluorescence method. Evaluations on occlusal and buccal surfaces were performed separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled, three-arm parallel, single-blinded, split-mouth clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Fuji II LC-Fuji Triage) | Experimental | Device: Fuji® II LC CAPSULE, Device: Fuji Triage® CAPSULEIn Group 1, newly erupted mandibular permanent first molars were sealed with resin-modified glass ionomers containing fissure sealant material (Fuji® II LC, GC Corporation, Tokyo, Japan) (test 1). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control). |
| Group 2 (Clinpro XT Varnish-Fuji Triage) | Experimental | Device: Clinpro™ XT Varnish, Device: Fuji Triage® CAPSULEIn Group 2, newly erupted mandibular permanent first molars were sealed with resin-modified glass ionomers containing fissure sealant material (Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USA) (test 2). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control). |
| Group 3 (Beautiful Flow- Fuji Triage) | Experimental | Device: Beautifil Flow, Device: Fuji Triage® CAPSULEIn Group 3, newly erupted mandibular permanent first molars were sealed with Giomer containing fissure sealant material (Beautifil Flow, Shofu, Kyoto, Japan) (test 3). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control). |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children who have two newly erupted non-carious mandibular permanent first molars that fissure sealant is indicated,
- Newly erupted first permanent molars show scores of 0 (Sound tooth surface)-1(First visual change in enamel) according to ICDAS II,
- Newly erupted first permanent molars show scores between 0-13 by using DIAGNOdent device,
- Children who haven't any systemic disease that prevents the application,
- Cooperative children who allowed the clinical applications.
Key exclusion criteria (5 listed)
- Teeth with proximal and initial caries,
- Teeth with applied fissure sealant,
- Teeth with developmental defects such as hypoplasia and restorations,
- Non-cooperative children who don't allow the clinical applications,
- Children and parents who denied the participation in the follow-up appointments.
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 |
|---|---|---|
| Fuji® II LC CAPSULEAlso: Fuji® II LC CAPSULE, GC Corporation, Tokyo, JapanFuji® II LC is a resin modified glass ionomer contained, fluoride releasing and light-cured material. Since the product is tolerant to moisture and saliva, it's used for fissure sealant of newly erupted teeth. Test 1 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.The tooth surface was rinsed with water and dried. Thereafter, Fuji® II LC was applied to the pits and fissures on the tooth surface using a brush. Then, the varnish was applied and cured according to the manufacturer's instructions. | Device | Group 1 (Fuji II LC-Fuji Triage) |
| Clinpro™ XT VarnishAlso: Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USAClinpro™ XT Varnish is a resin modified glass ionomer containing, fluoride-releasing, light-cured varnish. Since the product is tolerant to moisture and saliva, it is used for fissure sealant of newly erupted teeth. The product can be recharged with fluoride using fluoride-containing products. Test 2 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 35% phosphoric acid was applied to all surfaces of the tooth for 15 seconds.Then the tooth surface was rinsed with water and dried. Thereafter, Clinpro™ XT Varnish was applied in compliance with the manufacturers' instructions. | Device | Group 2 (Clinpro XT Varnish-Fuji Triage) |
| Beautifil FlowAlso: Beautifil Flow, Shofu, Kyoto, JapanBeautiful Flow is a Giomer contained, fluoride releasing and light cured material. The product contains pre-reacted glass ionomer particles (PRG). It is a high water resistant material. It is used for fissure sealant. Test 3 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 7% phosphoric acid was applied to all surfaces of the tooth for 10 seconds. Then the tooth surface was rinsed with water and dried. Afterwards, a two-stage self-etch adhesive system was applied. Thereafter, Beautiful Flow was applied in compliance with the manufacturers' instructions. | Device | Group 3 (Beautiful Flow- Fuji Triage) |
| Fuji Triage® CAPSULEAlso: Fuji Triage® CAPSULE, GC Corporation, Tokyo, JapanFuji Triage® is a new generation glass ionomer containing with low viscosity, high fluoride content and light curing materials. Since the product is tolerant of moisture and saliva, it is used for fissure sealant of newly erupted teeth. Control newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.Then the tooth surface was rinsed with water and dried. Thereafter,Fuji Triage® was applied to the pits and fissures on the tooth surface using a brush. Thereafter, the varnish was applied and cured according to the manufacturer's instructions. | Device | Group 1 (Fuji II LC-Fuji Triage), Group 2 (Clinpro XT Varnish-Fuji Triage), Group 3 (Beautiful Flow- Fuji Triage) |
Primary outcome
The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars.
Time frame: 18 months after the clinical applications
The primary outcome of the study was the assessment of clinical retention rates at 18th months.
The assessment of marginal adaptation rates of fissure sealants applied to newly erupted permanent first molars.
Time frame: 18 months after the clinical applications
The primary outcome of the study was the assessment of marginal adaptation rates at 18th months.
The assessment of marginal discoloration rates of fissure sealants applied to newly erupted permanent first molars.
Time frame: 18 months after the clinical applications
The primary outcome of the study was the assessment of marginal discoloration rates at 18th months.
The assessment of secondary caries rates of fissure sealants applied to newly erupted permanent first molars.
Time frame: 18 months after the clinical applications
The primary outcome of the study was the assessment of secondary caries rates at 18th months.
1 secondary outcome
The assessment of remineralization capacity using DIAGNOdent device
Time frame: 18 months after the clinical applications
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 6 May 2021.
- Individual participant dataSharing planned: No
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Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing
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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.
Merve Akcay, assoc. prof. study chair
Izmir Katip Celebi Uni
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fuji® II LC CAPSULE, Clinpro™ XT Varnish and Beautifil Flow in people with Fissure Sealant, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 6 May 2021. 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 Turkey (Türkiye). 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 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?
The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars. (time frame: 18 months after the clinical applications). The study lists 4 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 6 May 2021.