Pit and Fissure CariesNCT07018141
Wear Resistance Of Bioactive With And Without Etching Vs. Conventional Resin-Based Fissure Sealants
A study testing Bioactive Sealant with Etching: Participants in this group received a fluoride-releasing bioactive pit and fissure sealant (BeautiSealant, Shofu) applied after etching the tooth surface with 37% phosp and Bioactive Sealant without Etching: In this group, the same bioactive sealant (BeautiSealant, Shofu) was applied directly without acid etching. This simplified technique evaluates the sealant's effecti in people with Pit and Fissure Caries, run by Cairo University.
Trial summary
This randomized clinical trial aimed to compare the wear resistance and clinical performance of bioactive versus conventional resin-based pit and fissure sealants over a 12-month period. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Pit and Fissure Caries
- What is being tested?
- Bioactive Sealant with Etching: Participants in this group received a fluoride-releasing bioactive pit and fissure sealant (BeautiSealant, Shofu) applied after etching the tooth surface with 37% phosp and Bioactive Sealant without Etching: In this group, the same bioactive sealant (BeautiSealant, Shofu) was applied directly without acid etching. This simplified technique evaluates the sealant's effecti
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients aged between 18-25 years old with caries susceptible sound fissures and good oral hygiene
- They should not show any signs of caries by visual tactile examination method and VistaProof fluoroscent camera
- Teeth should have intact contact with opposing teeth, no previous restorations in other surfaces, no previous sealing procedures and scoring 0.9 or less when tested and VistaProof.
- Medically free patients.
Who cannot join
- Patients with poor oral hygiene, lack of compliance, parafunctional habits, tempro-mandibular joint disorders, periodontal disease, severe medical conditions, allergic history concerning methacrylates, rampant caries, heavy smoking and xerostomia.
- Teeth with caries pits and fissures, developmental anomalies, periapical pathology or signs of pulpal pathology, hypersensitivity, possible prosthodontic restoration, heavy occlusion and occlusal contacts, history of bruxism, severe periodontal affection and scoring >0.9 when tested with VistaProof
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical And Digital Evaluation Of Wear Resistance Of Bioactive Pits And Fissure Sealant With And Without Etching Versus Conventional Resin Based Pits And Fissure Sealants: A RANDOMIZED CLINICAL TRIAL
This randomized clinical trial aimed to compare the wear resistance and clinical performance of bioactive versus conventional resin-based pit and fissure sealants over a 12-month period. Conducted on young adults with sound, caries-susceptible molars, the study evaluated three groups: bioactive sealants applied with and without etching, and conventional resin-based sealants with etching. Clinical assessments and 3D digital scans were used to measure sealant retention and wear. The study seeks to determine whether bioactive sealants, especially when applied without etching, provide comparable long-term protection and durability to conventional sealants, potentially simplifying application without compromising effectiveness.
Read the detailed description
This study is a randomized controlled clinical trial designed to evaluate and compare the wear resistance and clinical performance of bioactive pit and fissure sealants-applied with and without acid etching-against conventional resin-based sealants in young adults aged 18-25 with caries-susceptible, sound first permanent molars. Seventy-five teeth were randomly assigned to three groups: Group 1 received a bioactive giomer-based sealant (BeautiSealant) with etching, Group 2 received the same sealant without etching, and Group 3 received a conventional resin-based sealant (Fisseal Promedica) with etching. Sealant retention and wear were evaluated clinically using modified USPHS criteria and digitally using intraoral 3D scanning at baseline, 6 months, and 12 months. The aim was to determine if omitting the etching step in bioactive sealants compromises their effectiveness, offering a simpler yet reliable alternative to conventional methods. The findings are expected to guide clinical decision-making on the most efficient and durable sealant protocols for caries prevention.
- Conditions
- Pit and Fissure Caries
- Being tested
- Bioactive Sealant with Etching: Participants in this group received a fluoride-releasing bioactive pit and fissure sealant (BeautiSealant, Shofu) applied after etching the tooth surface with 37% phosp, Bioactive Sealant without Etching: In this group, the same bioactive sealant (BeautiSealant, Shofu) was applied directly without acid etching. This simplified technique evaluates the sealant's effecti, Conventional Resin-Based Sealant with Etching (Control): This group received a conventional resin-based sealant (Fisseal, Promedica) following standard acid etching. This technique represents the trad
- Keywords
- Pit and Fissure Caries
- 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.
Bioactive Sealant with Etching: Participants in this group received a fluoride-releasing bioactive pit and fissure sealant (BeautiSealant, Shofu) applied after etching the tooth surface with 37% phospOther
This group received BeautiSealant (a bioactive giomer-based sealant) applied after etching the enamel surface with 37% phosphoric acid for 15 seconds. The etching process creates micro-retentive patterns in the enamel to enhance micromechanical bonding, potentially improving the sealant's retention and wear resistance while also benefiting from the bioactive material's fluoride release and enamel remineralization properties.
Bioactive Sealant without Etching: In this group, the same bioactive sealant (BeautiSealant, Shofu) was applied directly without acid etching. This simplified technique evaluates the sealant's effectiOther
In this group, BeautiSealant was applied directly to the tooth surface without prior etching. The goal was to simplify the procedure by eliminating the etching step, relying instead on the sealant's chemical bonding and bioactive properties (such as fluoride release and S-PRG technology) to maintain retention and resist wear, while reducing the risk of enamel alteration and improving clinical efficiency.
Conventional Resin-Based Sealant with Etching (Control): This group received a conventional resin-based sealant (Fisseal, Promedica) following standard acid etching. This technique represents the tradOther
This group served as the control and received Fisseal (a conventional resin-based sealant) applied following standard etching with 37% phosphoric acid. This method is considered the gold standard for fissure sealing, offering strong micromechanical adhesion and proven wear resistance, making it a reliable benchmark for evaluating the performance of newer bioactive materials.
| Study group | Role | What they receive |
|---|---|---|
| Fluoride Releasing bioactive Pit and Fissure Sealant with etchant | Experimental | Fluoride Releasing bioactive Pit and Fissure Sealant with etchant application. Receives: Other: Bioactive Sealant with Etching: Participants in this group received a fluoride-releasing bioactive pit and fissure sealant (BeautiSealant, Shofu) applied after etching the tooth surface with 37% phosp |
| Fluoride Releasing bioactive Pit and Fissure Sealant without etchant | Experimental | Fluoride Releasing bioactive Pit and Fissure Sealant without etchant application. Receives: Other: Bioactive Sealant without Etching: In this group, the same bioactive sealant (BeautiSealant, Shofu) was applied directly without acid etching. This simplified technique evaluates the sealant's effecti |
| conventional resin based pits and fissure sealant | Active comparator | Conventional resin-based sealant with etchant application Receives: Other: Conventional Resin-Based Sealant with Etching (Control): This group received a conventional resin-based sealant (Fisseal, Promedica) following standard acid etching. This technique represents the trad |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention of wear resistance of the sealants
modified USPHS criteria
Measured: 3,6,9 and 12 months
Secondary outcomes (1)
quantitative wear assesment
digital scanner
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2026 (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 CariesStudies 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, Investigator
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana hossam eldin mahfouz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018141
- Sponsor's protocol ID
- Operative 4
- Status last verified
- Jun 2025
- First submitted
- 21 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Digital Evaluation Of Wear Resistance Of Bioactive Pits And Fissure Sealant With And Without Etching Versus Conventional Resin Based Pits And Fissure Sealants: A RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT07018141
- Acronym / sponsor ID
- Operative 4
- Conditions
- Pit and Fissure Caries
- Keywords
- Pit and Fissure Caries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 12 Jun 2025 (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 randomized clinical trial aimed to compare the wear resistance and clinical performance of bioactive versus conventional resin-based pit and fissure sealants over a 12-month period. Conducted on young adults with sound, caries-susceptible molars, the study evaluated three groups: bioactive sealants applied with and without etching, and conventional resin-based sealants with etching. Clinical assessments and 3D digital scans were used to measure sealant retention and wear. The study seeks to determine whether bioactive sealants, especially when applied without etching, provide comparable long-term protection and durability to conventional sealants, potentially simplifying application without compromising effectiveness.
Detailed description
This study is a randomized controlled clinical trial designed to evaluate and compare the wear resistance and clinical performance of bioactive pit and fissure sealants-applied with and without acid etching-against conventional resin-based sealants in young adults aged 18-25 with caries-susceptible, sound first permanent molars. Seventy-five teeth were randomly assigned to three groups: Group 1 received a bioactive giomer-based sealant (BeautiSealant) with etching, Group 2 received the same sealant without etching, and Group 3 received a conventional resin-based sealant (Fisseal Promedica) with etching. Sealant retention and wear were evaluated clinically using modified USPHS criteria and digitally using intraoral 3D scanning at baseline, 6 months, and 12 months. The aim was to determine if omitting the etching step in bioactive sealants compromises their effectiveness, offering a simpler yet reliable alternative to conventional methods. The findings are expected to guide clinical decision-making on the most efficient and durable sealant protocols for caries prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluoride Releasing bioactive Pit and Fissure Sealant with etchant | Experimental | Other: Bioactive Sealant with Etching: Participants in this group received a fluoride-releasing bioactive pit and fissure sealant (BeautiSealant, Shofu) applied after etching the tooth surface with 37% phospFluoride Releasing bioactive Pit and Fissure Sealant with etchant application. |
| Fluoride Releasing bioactive Pit and Fissure Sealant without etchant | Experimental | Other: Bioactive Sealant without Etching: In this group, the same bioactive sealant (BeautiSealant, Shofu) was applied directly without acid etching. This simplified technique evaluates the sealant's effectiFluoride Releasing bioactive Pit and Fissure Sealant without etchant application. |
| conventional resin based pits and fissure sealant | Active comparator | Other: Conventional Resin-Based Sealant with Etching (Control): This group received a conventional resin-based sealant (Fisseal, Promedica) following standard acid etching. This technique represents the tradConventional resin-based sealant with etchant application |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients aged between 18-25 years old with caries susceptible sound fissures and good oral hygiene
- They should not show any signs of caries by visual tactile examination method and VistaProof fluoroscent camera
- Teeth should have intact contact with opposing teeth, no previous restorations in other surfaces, no previous sealing procedures and scoring 0.9 or less when tested and VistaProof.
- Medically free patients.
Key exclusion criteria (2 listed)
- Patients with poor oral hygiene, lack of compliance, parafunctional habits, tempro-mandibular joint disorders, periodontal disease, severe medical conditions, allergic history concerning methacrylates, rampant caries, heavy smoking and xerostomia.
- Teeth with caries pits and fissures, developmental anomalies, periapical pathology or signs of pulpal pathology, hypersensitivity, possible prosthodontic restoration, heavy occlusion and occlusal contacts, history of bruxism, severe periodontal affection and scoring >0.9 when tested with VistaProof
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 |
|---|---|---|
| Bioactive Sealant with Etching: Participants in this group received a fluoride-releasing bioactive pit and fissure sealant (BeautiSealant, Shofu) applied after etching the tooth surface with 37% phospThis group received BeautiSealant (a bioactive giomer-based sealant) applied after etching the enamel surface with 37% phosphoric acid for 15 seconds. The etching process creates micro-retentive patterns in the enamel to enhance micromechanical bonding, potentially improving the sealant's retention and wear resistance while also benefiting from the bioactive material's fluoride release and enamel remineralization properties. | Other | Fluoride Releasing bioactive Pit and Fissure Sealant with etchant |
| Bioactive Sealant without Etching: In this group, the same bioactive sealant (BeautiSealant, Shofu) was applied directly without acid etching. This simplified technique evaluates the sealant's effectiIn this group, BeautiSealant was applied directly to the tooth surface without prior etching. The goal was to simplify the procedure by eliminating the etching step, relying instead on the sealant's chemical bonding and bioactive properties (such as fluoride release and S-PRG technology) to maintain retention and resist wear, while reducing the risk of enamel alteration and improving clinical efficiency. | Other | Fluoride Releasing bioactive Pit and Fissure Sealant without etchant |
| Conventional Resin-Based Sealant with Etching (Control): This group received a conventional resin-based sealant (Fisseal, Promedica) following standard acid etching. This technique represents the tradThis group served as the control and received Fisseal (a conventional resin-based sealant) applied following standard etching with 37% phosphoric acid. This method is considered the gold standard for fissure sealing, offering strong micromechanical adhesion and proven wear resistance, making it a reliable benchmark for evaluating the performance of newer bioactive materials. | Other | conventional resin based pits and fissure sealant |
Primary outcome
retention of wear resistance of the sealants
Time frame: 3,6,9 and 12 months
modified USPHS criteria
1 secondary outcome
quantitative wear assesment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
Related trials for Pit and Fissure Caries
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Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing
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Active, not recruiting
Evaluation of the Clinical Success of Hydrophilic Fissure Sealants
Pit and Fissure Caries (Disorder), Pit and Fissure Sealants
Recruiting
Comparison of the Efficacy of Three Preventive Methods to Reduce the Incidence of Coronal Caries in Schoolchildren
Caries Prevention
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.
Questions about this trial
What is this clinical trial studying?
A study testing Bioactive Sealant with Etching: Participants in this group received a fluoride-releasing bioactive pit and fissure sealant (BeautiSealant, Shofu) applied after etching the tooth surface with 37% phosp and Bioactive Sealant without Etching: In this group, the same bioactive sealant (BeautiSealant, Shofu) was applied directly without acid etching. This simplified technique evaluates the sealant's effecti in people with Pit and Fissure Caries, 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 4 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: opening soon, as of the sponsor's last update on 12 Jun 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact rana hossam eldin, master (01004698643, rana.hossam@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 wear resistance of the sealants (time frame: 3,6,9 and 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 12 Jun 2025.