Pits and Fissure SealantsNCT07399340
A Comparative Evaluation of the Role of Self-Adhesive Flowable Composite in Enhancing Sealant Retention Versus Conventional Pits and Fissure Sealant With and Without Fissurotomy in Permanent Molars
A study testing Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy., Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy. and Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy. in people with Pits and Fissure Sealants, run by Cairo University at 2 sites in Egypt.
Trial summary
This RCT study aims to establish evidence-based decision comparing between self-adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) and conventional resin-based pits \& fissure sealant Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) with and without fissurotomy in sealant retention and… Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pits and Fissure Sealants
- What is being tested?
- Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy., Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy. and Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesEgypt
- Study dates
- Mar 2026to Jun 2027
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Normal healthy children aged 6 to 8 years.
- Children with high caries risk
- Completely erupted lower first permanent molars with deep pits and fissures.
- Fissures either intact, sound or retentive which are stained, caries free or ICDAS 0-2.
- Availability for the duration of the study.
- Satisfactory dental care performed at home.
Who cannot join
- Children whose parents refuse to sign informed consent.
- Long-term medication affecting the salivary flow.
- Children enrolled for other studies or fluoridation program.
- Adverse reaction reported to any dental material.
- Uncooperative child.
- Bruxism or malocclusion.
Show all 9Show fewer
- Children with developmental defects/ hypoplastic molars or caries affected teeth (ICDAS>2).
- Teeth with restoration and partially retained sealants.
- Children who cannot come for the follow-up.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Faculty of Dentistry, Cairo University
Cairo, State/Province *, 11411
00201121592653, eman.ramadan@dentistry.cu.edu.eg
Faculty of Dentistry, Cairo University
Cairo, State/Province *
Eman Ramadan, Bachelors', 00201121592653, eman.ramadan@dentistry.cu.edu.eg
About this study
Official title: A Comparative Evaluation of the Role of Self-Adhesive Flowable Composite in Enhancing Sealant Retention Versus Conventional Pits and Fissure Sealant With and Without Fissurotomy in Permanent Molars: A Randomized Controlled Trial
This RCT study aims to establish evidence-based decision comparing between self-adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) and conventional resin-based pits \& fissure sealant Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) with and without fissurotomy in sealant retention and prevention of occlusal pits and fissures caries in first permanent molars over a 12-month follow-up.
Read the detailed description
This randomized controlled clinical trial aims to compare the retention and clinical performance of a self-adhering flowable composite and a conventional resin-based pit and fissure sealant, applied with and without fissurotomy, in newly erupted permanent first molars of children aged 6-8 years.
Occlusal pits and fissures are highly susceptible to dental caries in children, and long-term sealant effectiveness is strongly dependent on material retention and technique sensitivity. Self-adhering flowable composites offer simplified application with fewer clinical steps and may improve retention, especially in pediatric patients.
Eighty-eight children will be randomly allocated into four parallel groups (1:1:1:1): self-adhering flowable composite with fissurotomy, self-adhering flowable composite without fissurotomy, conventional resin-based sealant with fissurotomy, and conventional resin-based sealant without fissurotomy.
Sealant retention will be assessed as the primary outcome using Simonsen's criteria, while secondary outcomes include caries development, marginal discoloration, and marginal integrity evaluated using Ryge criteria.
Clinical evaluations will be performed at baseline, 3, 6, and 12 months.
The findings of this study aim to provide evidence-based guidance on the optimal material and technique for pit and fissure sealing in children, potentially improving sealant longevity, reducing occlusal caries incidence, and enhancing preventive pediatric dental care.
- Conditions
- Pits and Fissure Sealants
- Being tested
- Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy., Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy., Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy., Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.
- Keywords
- Self-adhering flowable composite, Conventional pits and fissure sealant, Helioseal-F, Vertise Flow, Fissurotomy, Permanent molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy.Other
- Pits and fissures will be prepared using a Micro STF fissurotomy bur (SS White Burs Inc., Lakewood, NJ, USA) on a high-speed hand piece, the bur will be moved along all the occlusal fissures with a gentle force applied. (Bagherian et al., 2013)
- Then washing and drying the tooth with compressed air.
- Then self-adhering flowable composite (Vertise Flow, Kerr, Orange, CA, USA) with an A2 shade will be applied on occlusal fissures in 0.5mm and brushed on preparation for 15-20sec using a micro-brush with moderate pressure. (Sabbagh et al., 2017; Sharma et al., 2018)
- Excess material around the margins will be removed.
- After ensuring that there are no bubbles, the sealant will be cured for 20 seconds by light cure. (Woodpecker RTA Mini S, China).
- If necessary, another layer will be applied and cured for 20 seconds.
Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy.Other
- Before applying Vertise Flow, surface pretreatment according to the manufacturers' recommendations for uncut enamel.(Kucukyilmaz and Savas, 2015) Using 37.5 % phosphoric acid gel Ivoclar Vivadent AG, Schaan, Liechtenstein) for 30-60 seconds according to the manufacturer's instructions, rinsed for 60 seconds and air-dried with oil- and water-free air spray using clean compressed air until observing the chalky white appearance.
- Then self-adhering flowable composite (Vertise Flow, Kerr, Orange, CA, USA) with an A2 shade will be applied in 0.5mm and brushed on fissures for 15-20sec using a micro-brush with moderate pressure.(Sabbagh et al., 2017; Sharma et al., 2018)
- Remove excess material around the margins.
- After ensuring that there are no bubbles, the sealant will be cured for 20 seconds by light cure. (Woodpecker RTA Mini S, China).
- If necessary, another layer will be applied and cured for 20 seconds.
Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy.Other
- Pits and fissures will be prepared using a Micro STF fissurotomy bur (SS White Burs Inc., Lakewood, NJ, USA) on a high-speed hand piece, the bur will be moved along all the occlusal fissures with a gentle force applied. (Bagherian et al., 2013)
- Then the occlusal surface of the teeth will be dried and etched with 37% phosphoric acid (Ivoclar Vivadent AG, Schaan, Liechtenstein) for 15-30 seconds according to the manufacturer's instructions, rinsed for 30 seconds and air-dried with oil- and water-free air spray using clean compressed air until observing the chalky white appearance.
- Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) will be applied and directed into the pits and fissures by a sterile explorer to check that there are no air bubbles and light cured for 40 seconds by light cure. (Woodpecker RTA Mini S, China).
Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.Other
- The occlusal surface of the teeth will be dried and etched with 37% phosphoric acid (Ivoclar Vivadent AG, Schaan, Liechtenstein) for 30-60 seconds according to the manufacturer's instructions, rinsed for 30 seconds and air-dried with oil- and water-free air spray using clean compressed air until observing the chalky white appearance.
- Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) will be applied and directed into the pits and fissures by a sterile explorer to check that there are no air bubbles and light cured for 40 seconds by light cure. (Woodpecker RTA Mini S, China )
| Study group | Role | What they receive |
|---|---|---|
| Self adhering flowable composite Vertise™ Flow with fissurotomy | Experimental | Vertise™ Flow (Kerr, Orange, CA, USA)
Chemical composition:
* Resin: GPDMA, HEMA, BisGMA, catalysts.
* Fillers: Prepolymers, silanated Ba-glass, SiO2,YF3 (70 wt%). This SAFC uses the adhesive monomer glycerophosphate dimethacrylate GPDM, a phosphate functional group that creates a chemical bond with the calcium ions of the tooth. GPDM monomers ensure a tenacious bond to enamel, evidenced by the strength known to all generations of the OptiBond adhesive family. Receives: Other: Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy. |
| Self adhering flowable composite Vertise™ Flow without fissurotomy | Experimental | Vertise™ Flow (Kerr, Orange, CA, USA)
Chemical composition:
* Resin: GPDMA, HEMA, BisGMA, catalysts.
* Fillers: Prepolymers, silanated Ba-glass, SiO2,YF3 (70 wt%). This SAFC uses the adhesive monomer glycerophosphate dimethacrylate GPDM, a phosphate functional group that creates a chemical bond with the calcium ions of the tooth. GPDM monomers ensure a tenacious bond to enamel, evidenced by the strength known to all generations of the OptiBond adhesive family. Receives: Other: Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy. |
| Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy. | Active comparator | Resin-based pits and fissure sealant Helioseal-F 40% filler content, higher viscosity
Sealant Matrix Composition:
1. Bis-GMA
2. UDMA
3. TEGDMA Fillers: Fluorosilicate glass , highly dispersed silicon dioxide, pigments, initiators. Receives: Other: Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy. |
| Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy. | Active comparator | Resin-based pits and fissure sealant Helioseal-F 40% filler content, higher viscosity
Sealant Composition:
1. Bis-GMA
2. UDMA
3. TEGDMA Fillers: Fluorosilicate glass , highly dispersed silicon dioxide, pigments, initiators. Receives: Other: Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealant retention
Simonsen's criteria Score 1: Complete retention Score 2: Partial loss Score 3: Complete loss
Measured: 3,6,12 months
Secondary outcomes (3)
Presence of Caries
Ryge criteria Alpha: Absence of caries Bravo: Prescence of caries
Measured: 3,6,12 months
Marginal discoloration
Ryge criteria Alpha: No discoloration anywhere on the margin around the sealant. Bravo: Visible partial discoloration on the margin around sealant. Charlie: Visible discoloration on the margin around all sealant.
Measured: 3,6,12 months
Marginal Integrity
Ryge criteria Alpha: Sealant had full adaptation to the adjacent tooth structure. Bravo: Evidence of gap detected by the tip of an explorer.
Measured: 3,6,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pits and Fissure SealantsStudies 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
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre, Egypt
- Responsible party
- Principal investigator, Eman Mohamed Mostafa Ramadan, Cairo University
- Investigators
- Adel ELbardissy, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399340
- Sponsor's protocol ID
- CU-Pedo-2026
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of the Role of Self-Adhesive Flowable Composite in Enhancing Sealant Retention Versus Conventional Pits and Fissure Sealant With and Without Fissurotomy in Permanent Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07399340
- Acronym / sponsor ID
- CU-Pedo-2026
- Conditions
- Pits and Fissure Sealants
- Keywords
- Self-adhering flowable composite, Conventional pits and fissure sealant, Helioseal-F, Vertise Flow, Fissurotomy, Permanent molars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- National Research Centre, Egypt
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Feb 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.
This RCT study aims to establish evidence-based decision comparing between self-adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) and conventional resin-based pits \& fissure sealant Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) with and without fissurotomy in sealant retention and prevention of occlusal pits and fissures caries in first permanent molars over a 12-month follow-up.
Detailed description
This randomized controlled clinical trial aims to compare the retention and clinical performance of a self-adhering flowable composite and a conventional resin-based pit and fissure sealant, applied with and without fissurotomy, in newly erupted permanent first molars of children aged 6-8 years.
Occlusal pits and fissures are highly susceptible to dental caries in children, and long-term sealant effectiveness is strongly dependent on material retention and technique sensitivity. Self-adhering flowable composites offer simplified application with fewer clinical steps and may improve retention, especially in pediatric patients.
Eighty-eight children will be randomly allocated into four parallel groups (1:1:1:1): self-adhering flowable composite with fissurotomy, self-adhering flowable composite without fissurotomy, conventional resin-based sealant with fissurotomy, and conventional resin-based sealant without fissurotomy.
Sealant retention will be assessed as the primary outcome using Simonsen's criteria, while secondary outcomes include caries development, marginal discoloration, and marginal integrity evaluated using Ryge criteria.
Clinical evaluations will be performed at baseline, 3, 6, and 12 months.
The findings of this study aim to provide evidence-based guidance on the optimal material and technique for pit and fissure sealing in children, potentially improving sealant longevity, reducing occlusal caries incidence, and enhancing preventive pediatric dental care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Self adhering flowable composite Vertise™ Flow with fissurotomy | Experimental | Other: Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy.Vertise™ Flow (Kerr, Orange, CA, USA) Chemical composition: * Resin: GPDMA, HEMA, BisGMA, catalysts. * Fillers: Prepolymers, silanated Ba-glass, SiO2,YF3 (70 wt%). This SAFC uses the adhesive monomer glycerophosphate dimethacrylate GPDM, a phosphate functional group that creates a chemical bond with the calcium ions of the tooth. GPDM monomers ensure a tenacious bond to enamel, evidenced by the strength known to all generations of the OptiBond adhesive family. |
| Self adhering flowable composite Vertise™ Flow without fissurotomy | Experimental | Other: Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy.Vertise™ Flow (Kerr, Orange, CA, USA) Chemical composition: * Resin: GPDMA, HEMA, BisGMA, catalysts. * Fillers: Prepolymers, silanated Ba-glass, SiO2,YF3 (70 wt%). This SAFC uses the adhesive monomer glycerophosphate dimethacrylate GPDM, a phosphate functional group that creates a chemical bond with the calcium ions of the tooth. GPDM monomers ensure a tenacious bond to enamel, evidenced by the strength known to all generations of the OptiBond adhesive family. |
| Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy. | Active comparator | Other: Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy.Resin-based pits and fissure sealant Helioseal-F 40% filler content, higher viscosity Sealant Matrix Composition: 1. Bis-GMA 2. UDMA 3. TEGDMA Fillers: Fluorosilicate glass , highly dispersed silicon dioxide, pigments, initiators. |
| Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy. | Active comparator | Other: Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.Resin-based pits and fissure sealant Helioseal-F 40% filler content, higher viscosity Sealant Composition: 1. Bis-GMA 2. UDMA 3. TEGDMA Fillers: Fluorosilicate glass , highly dispersed silicon dioxide, pigments, initiators. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Normal healthy children aged 6 to 8 years.
- Children with high caries risk
- Completely erupted lower first permanent molars with deep pits and fissures.
- Fissures either intact, sound or retentive which are stained, caries free or ICDAS 0-2.
- Availability for the duration of the study.
Key exclusion criteria (9 listed)
- Children whose parents refuse to sign informed consent.
- Long-term medication affecting the salivary flow.
- Children enrolled for other studies or fluoridation program.
- Adverse reaction reported to any dental material.
- Uncooperative child.
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 adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy.1. Pits and fissures will be prepared using a Micro STF fissurotomy bur (SS White Burs Inc., Lakewood, NJ, USA) on a high-speed hand piece, the bur will be moved along all the occlusal fissures with a gentle force applied. (Bagherian et al., 2013) 2. Then washing and drying the tooth with compressed air. 3. Then self-adhering flowable composite (Vertise Flow, Kerr, Orange, CA, USA) with an A2 shade will be applied on occlusal fissures in 0.5mm and brushed on preparation for 15-20sec using a micro-brush with moderate pressure. (Sabbagh et al., 2017; Sharma et al., 2018) 4. Excess material around the margins will be removed. 5. After ensuring that there are no bubbles, the sealant will be cured for 20 seconds by light cure. (Woodpecker RTA Mini S, China). 6. If necessary, another layer will be applied and cured for 20 seconds. | Other | Self adhering flowable composite Vertise™ Flow with fissurotomy |
| Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy.1. Before applying Vertise Flow, surface pretreatment according to the manufacturers' recommendations for uncut enamel.(Kucukyilmaz and Savas, 2015) Using 37.5 % phosphoric acid gel Ivoclar Vivadent AG, Schaan, Liechtenstein) for 30-60 seconds according to the manufacturer's instructions, rinsed for 60 seconds and air-dried with oil- and water-free air spray using clean compressed air until observing the chalky white appearance. 2. Then self-adhering flowable composite (Vertise Flow, Kerr, Orange, CA, USA) with an A2 shade will be applied in 0.5mm and brushed on fissures for 15-20sec using a micro-brush with moderate pressure.(Sabbagh et al., 2017; Sharma et al., 2018) 3. Remove excess material around the margins. 4. After ensuring that there are no bubbles, the sealant will be cured for 20 seconds by light cure. (Woodpecker RTA Mini S, China). 5. If necessary, another layer will be applied and cured for 20 seconds. | Other | Self adhering flowable composite Vertise™ Flow without fissurotomy |
| Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy.1. Pits and fissures will be prepared using a Micro STF fissurotomy bur (SS White Burs Inc., Lakewood, NJ, USA) on a high-speed hand piece, the bur will be moved along all the occlusal fissures with a gentle force applied. (Bagherian et al., 2013) 2. Then the occlusal surface of the teeth will be dried and etched with 37% phosphoric acid (Ivoclar Vivadent AG, Schaan, Liechtenstein) for 15-30 seconds according to the manufacturer's instructions, rinsed for 30 seconds and air-dried with oil- and water-free air spray using clean compressed air until observing the chalky white appearance. 3. Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) will be applied and directed into the pits and fissures by a sterile explorer to check that there are no air bubbles and light cured for 40 seconds by light cure. (Woodpecker RTA Mini S, China). | Other | Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy. |
| Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy.1. The occlusal surface of the teeth will be dried and etched with 37% phosphoric acid (Ivoclar Vivadent AG, Schaan, Liechtenstein) for 30-60 seconds according to the manufacturer's instructions, rinsed for 30 seconds and air-dried with oil- and water-free air spray using clean compressed air until observing the chalky white appearance. 2. Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) will be applied and directed into the pits and fissures by a sterile explorer to check that there are no air bubbles and light cured for 40 seconds by light cure. (Woodpecker RTA Mini S, China ) | Other | Conventional resin-based pits and fissure sealant Helioseal-F without fissurotomy. |
Primary outcome
Sealant retention
Time frame: 3,6,12 months
Simonsen's criteria Score 1: Complete retention Score 2: Partial loss Score 3: Complete loss
3 secondary outcomes
Presence of Caries
Time frame: 3,6,12 months
Marginal discoloration
Time frame: 3,6,12 months
Marginal Integrity
Time frame: 3,6,12 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 10 Feb 2026.
- 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.
Adel ELbardissy, Professor study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) with fissurotomy., Self adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) without fissurotomy. and Conventional resin-based pits and fissure sealant Helioseal-F with fissurotomy. in people with Pits and Fissure Sealants, run by Cairo University at 2 sites 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 6 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: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Eman MM Ramadan, Bachelors' (+201121592653, eman.ramadan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sealant retention (time frame: 3,6,12 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 10 Feb 2026.