Pit and Fissure SealantPhase 2NCT06493942
Clinical Efficiency of Bioactive Pit and Fissure Sealant
A Phase 2 study testing BioCoat® by Premier® and UltraSeal XT™ plus by Ultradent in people with Pit and Fissure Sealant, run by Cairo University.
Trial summary
This study will compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing filled resin based pits and fissure sealant in posterior molars prone to carious lesions of fissures in patients at risk of caries. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pit and Fissure Sealant
- What is being tested?
- BioCoat® by Premier® and UltraSeal XT™ plus by Ultradent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 30 Sep 2025
- Phase
- Phase 2
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with caries susceptible fiss- ures in fully erupted first permanent molars showing nosigns of caries.
- Co-operative patients approving to part- icipate in the trial.
- Good oral hygiene.
- Caries susceptible occlusal pits and fissures.
- Intact contact with opposing teeth.
- Teeth with no previous restorations in other surfaces.
Who cannot join
- patients with Disabilities, systemic disease or severe medical complications.
- patients have allergic history concerning methacrylate.
- patients with rampant caries, xerostomia, evidence of severe bruxism, clenching, or tempromandibular joint disorders
- participants who show lack of compliance.
- Carious pits and fissures.
- Developmental tooth defect.
Show all 10Show fewer
- Partially erupted teeth
- Periapical pathology or signs of pulpal pathology.
- Tooth hypersensitivity.
- Heavy occlusion and occlusal contacts.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of Bioactive Versus Filled Resin Based Pit & Fissure Sealants in First Permanent Molars: A Randomized Controlled Trial
This study will compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing filled resin based pits and fissure sealant in posterior molars prone to carious lesions of fissures in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.
Read the detailed description
New bioactive resin pits and fissures sealant BioCoat® by Premier® presenting SmartCap™ Technology involving semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, supposing greater fluoride uptake in the presence of calcium and phosphate ions.
With no enough evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it isd beneficial to evaluate the newly introduced material using a randomized clinical trial to test the null hypothesis that bioactive resin pit and fissure sealant will have the same clinical performance as flouride releasing filled resin based pit and fissure sealant in susceptible fissures.
- Conditions
- Pit and Fissure Sealant
- Being tested
- BioCoat® by Premier®, UltraSeal XT™ plus by Ultradent
- Keywords
- dental sealant, pit and fissure sealant, fissure sealant, Bioactive dental sealant, Tooth sealant, Fissure sealants, Dental sealants, Pit sealants
- 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.
BioCoat® by Premier®Other
BioCoat is a 56% filled resin formula that provides added strength and excellent long-term resistance to wear ؤomparable to flowable composites.
UltraSeal XT™ plus by UltradentOther
UltraSeal XT plus is a 58%-filled resin fluoride-releasing sealant. It is strong and has high wear resistant
| Study group | Role | What they receive |
|---|---|---|
| Control group (A) | Active comparator | Fluoride releasing filled resin based pit and fissure sealant using UltraSeal XT™ plus by Ultradent Receives: Other: UltraSeal XT™ plus by Ultradent |
| Interventional group (B) | Experimental | Bioactive pit and fissure sealant using BioCoat® by Premier® Receives: Other: BioCoat® by Premier® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of sealant
rate of sealant loss
Measured: 1 year
Secondary outcomes (1)
Caries incidence
Rate of caries progression
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pit and 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samaa Salah Eldin Abd Elfattah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493942
- Sponsor's protocol ID
- BPFS
- Status last verified
- Jul 2024
- First submitted
- 2 Jul 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Bioactive Versus Filled Resin Based Pit & Fissure Sealants in First Permanent Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06493942
- Acronym / sponsor ID
- BPFS
- Conditions
- Pit and Fissure Sealant
- Keywords
- dental sealant, pit and fissure sealant, fissure sealant, Bioactive dental sealant, Tooth sealant, Fissure sealants, Dental sealants, Pit sealants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 10 Jul 2024 (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.
This study will compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing filled resin based pits and fissure sealant in posterior molars prone to carious lesions of fissures in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.
Detailed description
New bioactive resin pits and fissures sealant BioCoat® by Premier® presenting SmartCap™ Technology involving semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, supposing greater fluoride uptake in the presence of calcium and phosphate ions.
With no enough evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it isd beneficial to evaluate the newly introduced material using a randomized clinical trial to test the null hypothesis that bioactive resin pit and fissure sealant will have the same clinical performance as flouride releasing filled resin based pit and fissure sealant in susceptible fissures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Control group (A) | Active comparator | Other: UltraSeal XT™ plus by UltradentFluoride releasing filled resin based pit and fissure sealant using UltraSeal XT™ plus by Ultradent |
| Interventional group (B) | Experimental | Other: BioCoat® by Premier®Bioactive pit and fissure sealant using BioCoat® by Premier® |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
Key exclusion criteria (10 listed)
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 |
|---|---|---|
| BioCoat® by Premier®BioCoat is a 56% filled resin formula that provides added strength and excellent long-term resistance to wear ؤomparable to flowable composites. | Other | Interventional group (B) |
| UltraSeal XT™ plus by UltradentUltraSeal XT plus is a 58%-filled resin fluoride-releasing sealant. It is strong and has high wear resistant | Other | Control group (A) |
Primary outcome
Retention of sealant
Time frame: 1 year
rate of sealant loss
1 secondary outcome
Caries incidence
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Pit and 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
RecruitingObservational study
Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth
Dental Enamel, Dental Enamel Hypomineralization
Active, not recruiting
One-year Survival of Fissure Sealants in Immature Permanent Molars
Evaluation of the Survival of Different Fissure Sealants in Partially Erupted Immature Molar Teeth at Various Eruption Stages
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BioCoat® by Premier® and UltraSeal XT™ plus by Ultradent in people with Pit and Fissure Sealant, run by Cairo University.
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 6 inclusion and 10 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 10 Jul 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Samaa Salah, Msc (01009273452, samaa.salah@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of sealant (time frame: 1 year). 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 10 Jul 2024.