Fissure SealantNCT05336162
Retention Rate and Caries Preventive Effect of Self Etch Giomer Based Fissure Sealant
A study testing Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA) in people with Fissure Sealant, run by Cairo University at 1 site in Egypt.
Trial summary
With limited evidence-based information in literature about using giomer based pit and fissure sealant(BeautiSealant) in non-cavitated pits and fissures in permanent molars, it is beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that this new… Read more about this study
- Who is it for?
- Ages 16 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Fissure Sealant
- What is being tested?
- Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2023to 25 Jun 2024
- 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 16 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Young adults (16-22 y).
- Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
- Permanent molars teeth without any caries and cavitation.
- Permanent molar teeth that have deep pit and fissure morphology, with "sticky" fissures. •Permanent molar teeth with stained grooves.
- Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).
Who cannot join
- Uncooperative behavior, limits the use of sealants due to hampering of adequate field or isolation techniques throughout the procedure.
- Patients allergic to sealant material.
- Patient with history of medical disease, drug therapies or any other serious relevant problem.
- An individual with no previous caries experience and well coalesced pits and fissures
- Partially erupted teeth.
- Teeth with cavitation or caries of the dentin.
Show all 9Show fewer
- A large restoration is present on occlusal Surface.
- If pits and fissures are self-cleansable.
- Teeth with dental fluorosis, hypocalcification or hyper calcification.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Radwa Wael
Cairo
radwa wael, 01274268817, radwa.wael@dentistry.cu.edu.eg
Rania Mossalam
About this study
Official title: Retention Rate and Caries Preventive Effect of Self Etch Giomer Based Fissure Sealant Versus Total Etch Resin Based Fissure Sealant in Patients With Non- Cavitated Pits and Fissures in Permanent Molars Over One Year.
With limited evidence-based information in literature about using giomer based pit and fissure sealant(BeautiSealant) in non-cavitated pits and fissures in permanent molars, it is beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that this new pit and fissure sealant (BeautiSealant, Shoufu, USA). will have the same effect as resin based pit and fissure sealant (UltraSeal XT™ plus, Ultradent, USA) regarding retention rate and caries preventive effect.
Read the detailed description
Giomer is an adhesive material in dentistry made from resin that contains a Pre-Reacted Glass- ionomer (PRG) filler. The advantages of Giomer include the release and recharge of fluoride, resistance to acid, anti-plaque effect, remineralization of dentin, and acid buffering capacity. The surface pre-reacted glass-ionomer filler containing sealant (BeautiSealant) demonstrated superior fluoride recharging properties. BeautiSealant is filled with Shofu's proprietary S-PRG (Surface Pre-Reacted Glass) with cariostatic properties, acid neutralization, and plaque inhibition decreasing the risk for secondary caries. Beautisealant unlike traditional sealants which require phosphoric acid etching, demineralizing and dehydrating healthy teeth, shoufu's self etching primer is significantly less acidic helping to preserve healthy tooth structure and still maintaining equal or better shear bond strength. The clinical use of self-etching agents could be recommended before pit and fissure sealants application in new dental protocols. No clinical trials have been published uptill now evaluating caries incidence around giomer based fissure sealant by VistaCam iX proof. The aim of this study is to Evaluate the retention rate of self etch giomer based fissure sealant and also caries incidence using VistaCamiX.
- Conditions
- Fissure Sealant
- Being tested
- Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA)Other
A fissure sealant providing a physical barrier that inhibits microorganisms and food particles accumulation, preventing caries initiation, and arresting caries progression
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-cavitated pits and fissures in permanent molars will be treated with BeautiSealant | Experimental | Young adults (16-22 y) who have existing pits and fissures that are anatomically deep and caries susceptible or with Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2). Receives: Other: Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA) |
| Patients with non-cavitated pits and fissures in permanent molars will be treated with UltraSeal XT | Active comparator | Young adults (16-22 y) who have existing pits and fissures that are anatomically deep and caries susceptible or with Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2). Receives: Other: Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate of sealant
1-Full retention: the materials were fully present on the occlusal surfaces. 2- Partially lost: the materials were present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed. 3-Totally lost: no trace of materials was detected on the surface.
Measured: 12 months
Secondary outcomes (1)
Caries Incidence
Intra-oral fluorescence camera VistaCamiX proof camera using (Software Program)
Measured: T0=Baseline immediate postoperative. T1= 3 months follow up. T2= 6 months follow up. T3=12 months follow
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start25 Jan 2023
- Primary completion25 Jan 2024 (estimated)
- Study completion25 Jun 2024 (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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Wael Maher, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336162
- Sponsor's protocol ID
- giomer based fissure sealant
- Status last verified
- Mar 2023
- First submitted
- 8 Apr 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention Rate and Caries Preventive Effect of Self Etch Giomer Based Fissure Sealant Versus Total Etch Resin Based Fissure Sealant in Patients With Non- Cavitated Pits and Fissures in Permanent Molars Over One Year.
- ClinicalTrials.gov ID
- NCT05336162
- Acronym / sponsor ID
- giomer based fissure sealant
- Conditions
- Fissure Sealant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 25 Jan 2024 (estimated)
- Study completion
- 25 Jun 2024 (estimated)
- First posted
- 20 Apr 2022 (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.
With limited evidence-based information in literature about using giomer based pit and fissure sealant(BeautiSealant) in non-cavitated pits and fissures in permanent molars, it is beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that this new pit and fissure sealant (BeautiSealant, Shoufu, USA). will have the same effect as resin based pit and fissure sealant (UltraSeal XT™ plus, Ultradent, USA) regarding retention rate and caries preventive effect.
Detailed description
Giomer is an adhesive material in dentistry made from resin that contains a Pre-Reacted Glass- ionomer (PRG) filler. The advantages of Giomer include the release and recharge of fluoride, resistance to acid, anti-plaque effect, remineralization of dentin, and acid buffering capacity. The surface pre-reacted glass-ionomer filler containing sealant (BeautiSealant) demonstrated superior fluoride recharging properties. BeautiSealant is filled with Shofu's proprietary S-PRG (Surface Pre-Reacted Glass) with cariostatic properties, acid neutralization, and plaque inhibition decreasing the risk for secondary caries. Beautisealant unlike traditional sealants which require phosphoric acid etching, demineralizing and dehydrating healthy teeth, shoufu's self etching primer is significantly less acidic helping to preserve healthy tooth structure and still maintaining equal or better shear bond strength. The clinical use of self-etching agents could be recommended before pit and fissure sealants application in new dental protocols. No clinical trials have been published uptill now evaluating caries incidence around giomer based fissure sealant by VistaCam iX proof. The aim of this study is to Evaluate the retention rate of self etch giomer based fissure sealant and also caries incidence using VistaCamiX.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with non-cavitated pits and fissures in permanent molars will be treated with BeautiSealant | Experimental | Other: Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA)Young adults (16-22 y) who have existing pits and fissures that are anatomically deep and caries susceptible or with Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2). |
| Patients with non-cavitated pits and fissures in permanent molars will be treated with UltraSeal XT | Active comparator | Other: Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA)Young adults (16-22 y) who have existing pits and fissures that are anatomically deep and caries susceptible or with Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2). |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Young adults (16-22 y).
- Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
- Permanent molars teeth without any caries and cavitation.
- Permanent molar teeth that have deep pit and fissure morphology, with "sticky" fissures. •Permanent molar teeth with stained grooves.
- Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).
Key exclusion criteria (9 listed)
- Uncooperative behavior, limits the use of sealants due to hampering of adequate field or isolation techniques throughout the procedure.
- Patients allergic to sealant material.
- Patient with history of medical disease, drug therapies or any other serious relevant problem.
- An individual with no previous caries experience and well coalesced pits and fissures
- Partially erupted 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 |
|---|---|---|
| Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA)A fissure sealant providing a physical barrier that inhibits microorganisms and food particles accumulation, preventing caries initiation, and arresting caries progression | Other | Patients with non-cavitated pits and fissures in permanent molars will be treated with BeautiSealant, Patients with non-cavitated pits and fissures in permanent molars will be treated with UltraSeal XT |
Primary outcome
Retention Rate of sealant
Time frame: 12 months
1-Full retention: the materials were fully present on the occlusal surfaces. 2- Partially lost: the materials were present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed. 3-Totally lost: no trace of materials was detected on the surface.
1 secondary outcome
Caries Incidence
Time frame: T0=Baseline immediate postoperative. T1= 3 months follow up. T2= 6 months follow up. T3=12 months follow
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self etch giomer based fissure sealant (BeautiSealant, Shoufu, USA) in people with Fissure Sealant, run by Cairo University at 1 site in Egypt.
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 9 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 29 Mar 2023. 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate of sealant (time frame: 12 months). 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 29 Mar 2023.