Caries; InitialNCT05891288
Sealing of Initial Occlusal Caries Using Fissure Sealants
A study testing BioCoat® by Premier® and 3M™ Clinpro™ Sealant. in people with Caries; Initial, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing resin based pits and fissure sealant in initial carious lesions of fissures in posterior molars in patients at risk of caries. Read more about this study
- Who is it for?
- Ages 19 to 30 years
- Conditions the study is for
- Caries; Initial
- What is being tested?
- BioCoat® by Premier® and 3M™ Clinpro™ Sealant.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 1 Mar 2025
- 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 19 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with bilateral initial carious fissures in molars showing no signs of caries.
- Co-operative patients approving to participate in the trial.
Who cannot join
- Sound fissures.
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Rampant caries.
- Heavy smoking.
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- Xerostomia.
- Lack of compliance.
- Evidence of severe bruxism, clenching, or tempromandibular joint disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sealing of Initial Occlusal Caries in Fissures of Permanent Molars Using Bioactive Versus Fluoride Releasing Fissure Sealants: A Randomized Controlled Trial
The purpose of this study is to compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing resin based pits and fissure sealant in initial carious lesions of fissures in posterior molars in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.
Read the detailed description
SmartCap™ Technology, which is used in the novel bioactive fissure sealant, is based on proprietary semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules in BioCoat are packed with ionic fluoride, calcium, and phosphate solutions that diffuse in and out of the sealant. It is hypothesized that fluoride uptake is increased in the presence of calcium and phosphate ions.
With little evidence-based information in the literature about using bioactive fissure sealants to seal initial carious lesions, it was determined that a randomized controlled trial would be beneficial in testing the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as fluoride releasing resin-based pits and fissure sealant in fissures with initial caries.
- Conditions
- Caries; Initial
- Being tested
- BioCoat® by Premier®, 3M™ Clinpro™ Sealant.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioCoat® by Premier®Other
Bioactive pits and fissure sealant
3M™ Clinpro™ Sealant.Other
Fluoride releasing pits and fissure sealant
| Study group | Role | What they receive |
|---|---|---|
| bioactive group | Experimental | Bioactive Pits \& fissures sealant BioCoat® by Premier®. Receives: Other: BioCoat® by Premier® |
| Comparator group | Active comparator | Fluoride releasing resin based Pits \& fissures sealant 3M™ Clinpro™ Sealant Receives: Other: 3M™ Clinpro™ Sealant. |
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: 2 years
Secondary outcomes (1)
Caries incidence
Rate of caries progression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries; InitialStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Osama Shaalan, Cairo University
- Investigators
- Omar Shaalan, Principal investigator, Lecturer, Department of Conservative Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891288
- Sponsor's protocol ID
- Bioactive fissue sealant
- Status last verified
- Mar 2025
- First submitted
- 22 May 2023
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelsalam AF, Shaalan O. 24-month efficacy of bioactive versus fluoride sealant for non-cavitated occlusal caries in adults: a randomized clinical trial. Sci Rep. 2025 Dec 11;15(1):43738. doi: 10.1038/s41598-025-29730-8.
PubMed 41381619
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sealing of Initial Occlusal Caries in Fissures of Permanent Molars Using Bioactive Versus Fluoride Releasing Fissure Sealants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05891288
- Acronym / sponsor ID
- Bioactive fissue sealant
- Conditions
- Caries; Initial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 6 Jun 2023 (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 purpose of this study is to compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing resin based pits and fissure sealant in initial carious lesions of fissures in posterior molars in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.
Detailed description
SmartCap™ Technology, which is used in the novel bioactive fissure sealant, is based on proprietary semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules in BioCoat are packed with ionic fluoride, calcium, and phosphate solutions that diffuse in and out of the sealant. It is hypothesized that fluoride uptake is increased in the presence of calcium and phosphate ions.
With little evidence-based information in the literature about using bioactive fissure sealants to seal initial carious lesions, it was determined that a randomized controlled trial would be beneficial in testing the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as fluoride releasing resin-based pits and fissure sealant in fissures with initial caries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bioactive group | Experimental | Other: BioCoat® by Premier®Bioactive Pits \& fissures sealant BioCoat® by Premier®. |
| Comparator group | Active comparator | Other: 3M™ Clinpro™ Sealant.Fluoride releasing resin based Pits \& fissures sealant 3M™ Clinpro™ Sealant |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with bilateral initial carious fissures in molars showing no signs of caries.
- Co-operative patients approving to participate in the trial.
Key exclusion criteria (9 listed)
- Sound fissures.
- Pregnancy.
- Disabilities.
- Systemic disease or severe medical complications.
- Rampant caries.
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®Bioactive pits and fissure sealant | Other | bioactive group |
| 3M™ Clinpro™ Sealant.Fluoride releasing pits and fissure sealant | Other | Comparator group |
Primary outcome
Retention of sealant
Time frame: 2 years
rate of sealant loss
1 secondary outcome
Caries incidence
Time frame: 2 years
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 24 Mar 2025.
- Derived from this study: PubMed 41381619Abdelsalam AF, Shaalan O. 24-month efficacy of bioactive versus fluoride sealant for non-cavitated occlusal caries in adults: a randomized clinical trial. Sci Rep. 2025 Dec 11;15(1):43738. doi: 10.1038/s41598-025-29730-8.
- 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.
Omar Shaalan principal investigator
Lecturer, Department of Conservative Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioCoat® by Premier® and 3M™ Clinpro™ Sealant. in people with Caries; Initial, 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 2 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: finished, as of the sponsor's last update on 24 Mar 2025. 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?
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?
Retention of sealant (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05891288, which also lists 1 linked publication.
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 24 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.