RetentionNCT07705633
Evaluation of Two Pit and Fissure Sealants Treated by Two Remineralizing Agents in Resin Restorations
A study testing Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid, Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste and Group 3 : Teeth treated with prevent seal, Itena, North America after treating with Biflourid in people with Retention and Fissure Sealants, run by Ismail Dahshan at 1 site in Egypt.
Trial summary
The study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Retention, Fissure Sealants, Resin
- What is being tested?
- Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid, Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste and Group 3 : Teeth treated with prevent seal, Itena, North America after treating with Biflourid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2025to 1 Jan 2026
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Absence of restorations or prior sealants on the teeth under study.
- Patients have simple occlusal spot caries lesions
- Age group 15 - 40 years.
- Ability to return for periodic follow-up
Who cannot join
- Patients with high DMFS.
- Any fixed orthodontic appliances.
- Smoking habit.
- Pregnant and lactating mothers
- Symptoms of dental pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Two Pit and Fissure Sealants Treated by Two Remineralizing Agents in Preventive Resin Restorations
The study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations.
Primary objectives:
Assessment of retention rate and marginal integrity of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria and Simonsen's criteria.
Secondary objectives:
Assessment of stability of results after 3, 6 and 9months.
Read the detailed description
Dental caries is one of the most common intraoral diseases, with serious consequences for both the individual patient and for the public in terms of medical, social, and economic concerns. The individual patient suffers from pain, dysfunction of the oral system, and reduced quality of life.
Caries predominantly attack the occlusal surfaces of premolars and molars during their eruption . On the other hand, smooth surface caries have shown a significant decline, likely a result of increased worldwide access to fluoride . In previous reports, an incomplete post-eruptive maturation , and the presence of narrow and deep fissures were blamed for the increased caries susceptibility of occlusal surfaces . It has been more than 40 years since the pit and fissure sealants were first used clinically. During this time, pit and fissure sealants have been shown to be effective in reducing the risk of occlusal caries . A study aimed to evaluate the effect of the previous application of a casein phosphopeptide-amorphous calcium phosphate paste (MI Paste, MI) and adhesive systems on the bond durability of a fissure sealant. Ninety-eight enamel blocks were obtained from proximal surfaces of erupted third molars.
Anthor study evaluated the effect of treating the enamel with topical fluoride gel prior to acid etching on sealant retention clinically (Part I) and in vitro (Part II). Results showed no statistically significant differences between the test and control groups either clinically or in vitro. It is concluded that topical fluoride application prior to acid etching does not have a deleterious effect on sealant retention .
The study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations.
- Conditions
- Retention, Fissure Sealants, Resin, Pit and Fissure Sealants
- Being tested
- Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid, Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, Group 3 : Teeth treated with prevent seal, Itena, North America after treating with Biflourid, Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste
- Keywords
- Remineralizing Agents, Resin Restorations, Sealants, Pit and Fissure Sealant
- 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.
Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with BiflouridDevice
Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany
Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI PasteDevice
Group 2 (G2): Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America
Group 3 : Teeth treated with prevent seal, Itena, North America after treating with BiflouridDevice
Group 3 (G3): Teeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany
Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI PasteDevice
Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste
| Study group | Role | What they receive |
|---|---|---|
| Fisseal, Promedica Dental Material GmbH with Biflourid 10 Group | Experimental | Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany Receives: Device: Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid |
| Fisseal, Promedica Dental Material GmbH after treating with MI Paste Group | Experimental | Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America Receives: Device: Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste |
| prevent seal, Itena, North America after treating with Biflourid Group | Experimental | Teeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany Receives: Device: Group 3 : Teeth treated with prevent seal, Itena, North America after treating with Biflourid |
| prevent seal, Itena, North America after treating with MI Paste Group | Experimental | Teeth treated with prevent seal, Itena, North America after treating with MI Paste, GC AmericaC America Receives: Device: Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention rate of two types of pit and fissure sealants
Assessment of retention rate of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria
Measured: After 3 months, 6 months and 9 months
Secondary outcomes (1)
marginal integrity assessments
Assessment of marginal integrity of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria
Measured: After 3 months, 6 months and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start28 Feb 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetentionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ismail Dahshan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ismail Dahshan, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705633
- Sponsor's protocol ID
- 376/2021
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Two Pit and Fissure Sealants Treated by Two Remineralizing Agents in Preventive Resin Restorations
- ClinicalTrials.gov ID
- NCT07705633
- Acronym / sponsor ID
- 376/2021
- Conditions
- Retention, Fissure Sealants, Resin, Pit and Fissure Sealants
- Keywords
- Remineralizing Agents, Resin Restorations, Sealants, Pit and Fissure Sealant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ismail DahshanUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 15 Jul 2026 (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 study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations.
Primary objectives:
Assessment of retention rate and marginal integrity of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria and Simonsen's criteria.
Secondary objectives:
Assessment of stability of results after 3, 6 and 9months.
Detailed description
Dental caries is one of the most common intraoral diseases, with serious consequences for both the individual patient and for the public in terms of medical, social, and economic concerns. The individual patient suffers from pain, dysfunction of the oral system, and reduced quality of life.
Caries predominantly attack the occlusal surfaces of premolars and molars during their eruption . On the other hand, smooth surface caries have shown a significant decline, likely a result of increased worldwide access to fluoride . In previous reports, an incomplete post-eruptive maturation , and the presence of narrow and deep fissures were blamed for the increased caries susceptibility of occlusal surfaces . It has been more than 40 years since the pit and fissure sealants were first used clinically. During this time, pit and fissure sealants have been shown to be effective in reducing the risk of occlusal caries . A study aimed to evaluate the effect of the previous application of a casein phosphopeptide-amorphous calcium phosphate paste (MI Paste, MI) and adhesive systems on the bond durability of a fissure sealant. Ninety-eight enamel blocks were obtained from proximal surfaces of erupted third molars.
Anthor study evaluated the effect of treating the enamel with topical fluoride gel prior to acid etching on sealant retention clinically (Part I) and in vitro (Part II). Results showed no statistically significant differences between the test and control groups either clinically or in vitro. It is concluded that topical fluoride application prior to acid etching does not have a deleterious effect on sealant retention .
The study aimed to assess the clinical evaluation of two different types of pit and fissure sealants after treating with two different remineralizing agents in preventive resin restorations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fisseal, Promedica Dental Material GmbH with Biflourid 10 Group | Experimental | Device: Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with BiflouridTeeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany |
| Fisseal, Promedica Dental Material GmbH after treating with MI Paste Group | Experimental | Device: Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI PasteTeeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America |
| prevent seal, Itena, North America after treating with Biflourid Group | Experimental | Device: Group 3 : Teeth treated with prevent seal, Itena, North America after treating with BiflouridTeeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany |
| prevent seal, Itena, North America after treating with MI Paste Group | Experimental | Device: Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI PasteTeeth treated with prevent seal, Itena, North America after treating with MI Paste, GC AmericaC America |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Absence of restorations or prior sealants on the teeth under study.
- Patients have simple occlusal spot caries lesions
- Age group 15 - 40 years.
- Ability to return for periodic follow-up
Key exclusion criteria (5 listed)
- Patients with high DMFS.
- Any fixed orthodontic appliances.
- Smoking habit.
- Pregnant and lactating mothers
- Symptoms of dental pain
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 |
|---|---|---|
| Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with BiflouridTeeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid 10, Voco, Germany | Device | Fisseal, Promedica Dental Material GmbH with Biflourid 10 Group |
| Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI PasteGroup 2 (G2): Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste, GC AmericaC America | Device | Fisseal, Promedica Dental Material GmbH after treating with MI Paste Group |
| Group 3 : Teeth treated with prevent seal, Itena, North America after treating with BiflouridGroup 3 (G3): Teeth treated with prevent seal, Itena, North America after treating with Biflourid 10, Voco, Germany | Device | prevent seal, Itena, North America after treating with Biflourid Group |
| Group 4 : Teeth treated with prevent seal, Itena, North America after treating with MI PasteGroup 4 : Teeth treated with prevent seal, Itena, North America after treating with MI Paste | Device | prevent seal, Itena, North America after treating with MI Paste Group |
Primary outcome
Retention rate of two types of pit and fissure sealants
Time frame: After 3 months, 6 months and 9 months
Assessment of retention rate of two types of pit and fissure sealants when using two types of remeneralizing agents using Ryge's criteria
1 secondary outcome
marginal integrity assessments
Time frame: After 3 months, 6 months and 9 months.
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 15 Jul 2026.
- Individual participant dataSharing planned: Yes. It will be available if it needed
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with Biflourid, Group 2 :Teeth treated with Fisseal, Promedica Dental Material GmbH after treating with MI Paste and Group 3 : Teeth treated with prevent seal, Itena, North America after treating with Biflourid in people with Retention and Fissure Sealants, run by Ismail Dahshan 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 4 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 15 Jul 2026. 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 rate of two types of pit and fissure sealants (time frame: After 3 months, 6 months and 9 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 15 Jul 2026.