Pit and Fissure Caries (Disorder)NCT07262502
Evaluation of the Clinical Success of Hydrophilic Fissure Sealants
A study testing pit and fissure sealant in people with Pit and Fissure Caries (Disorder) and Pit and Fissure Sealants, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The study group will consist of children aged 7-11 years who are systemically healthy and who apply to the Pediatric Dentistry Clinic of the Faculty of Dentistry, Afyonkarahisar Health Sciences University for routine dental treatment. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Pit and Fissure Caries (Disorder), Pit and Fissure Sealants
- What is being tested?
- pit and fissure sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 Apr 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Patients aged 7-11 who applied for dental examination at the Department of Pediatric Dentistry, Faculty of Dentistry, Afyon Health Sciences University.
- 2. Patients must be systemically healthy and have no mental or physical disabilities.
- 3. Permanent first molars must be fully erupted in the mouth, and at least 3 first molars must be indicated for non-invasive fissure sealant application (having narrow, deep fissures prone to decay).
- 4. Permanent first molars to receive fissure sealants must not have hypomineralized areas such as fluorosis or first molar incisal hypomineralization.
- 5. Permanent first molars must not have occlusal or approximal caries.
Who cannot join
- 1. Patients must not be between the ages of 7 and 11. 2. Patients must not be systemically healthy and must have no mental or physical disabilities.
- 3. Patients must have poor oral hygiene. 4. There must be caries in the permanent first molars where fissure sealants will be applied.
- 5. Presence of hypomineralized areas such as fluorosis or first molar hypomineralization on the permanent first molars where fissure sealants will be applied.
- 6. Patients not cooperating with the procedures to be performed. 7. Patients or their parents not wanting to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Afyonkarahisar, Afyonkarahisar, 03030
About this study
Official title: EVALUATION OF THE CLINICAL SUCCESS OF A HYDROPHILIC FISSURE SEALANT APPLIED TO LOWER PERMANENT MOLARS UNDER DRY AND WET CONDITIONS
The study group will consist of children aged 7-11 years who are systemically healthy and who apply to the Pediatric Dentistry Clinic of the Faculty of Dentistry, Afyonkarahisar Health Sciences University for routine dental treatment.
In the study, fissure sealants will be applied to the first molars with opposing deep pits and fissures in the same jaw.
Read more
The study will involve the application of fissure sealants to the first molars with opposing deep pits and fissures in the same jaw.
It was decided to include a total of 500 teeth from 250 patients in the study, with 250 teeth in each group.
The occlusal surface of each tooth will be dried and etched with 37% phosphoric acid (Eco-Etch; Ivoclar Vivadent, Inc. Schaan, Liechtenstein) and thoroughly rinsed for 30 seconds.
If saliva contamination occurs, the surface will be etched again. The treated tooth will be air-dried for 3 seconds and the tooth in the opposing jaw for 15 seconds. Subsequently, the relevant fissure sealant (Pulpdent, Embrace Wetbond Pit and Fissure Sealant) will be applied to the occlusal surface of each tooth and cured for 20 seconds using a light-curing unit at an intensity of 500 mW/cm².
After restoration, articulation paper will be used to check for any high spots in the occlusion; if found, excess material will be removed using a finishing bur.
Clinical evaluations of marginal integrity, marginal color change, and retention after the liner is placed will be performed at 3, 6, 9, and 12 months using the World Health Organization probe according to the Ryge and Synder criteria.
- Being tested
- pit and fissure sealant
- Keywords
- pit and fissure sealants, Preventive Dentistry
- 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.
pit and fissure sealantOther
For each tooth to be treated with pit and fissure sealant, phosphoric acid will be used for pre-treatment. One group will be dried with an air-water spray for 3 seconds, while the drying time for the other group of teeth in the opposing jaw will be 15 seconds.
| Study group | Role | What they receive |
|---|---|---|
| pit and fissure sealant treatment | Experimental | Not described Receives: Other: pit and fissure sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edge discoloration
A: No color change between the restoration and the tooth structure B: Localized, mostly removable superficial color change C: Pulpal discoloration
Measured: 3-6-9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Apr 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 Caries (Disorder)Studies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ünal, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262502
- Sponsor's protocol ID
- 24.DUS.010
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE CLINICAL SUCCESS OF A HYDROPHILIC FISSURE SEALANT APPLIED TO LOWER PERMANENT MOLARS UNDER DRY AND WET CONDITIONS
- ClinicalTrials.gov ID
- NCT07262502
- Acronym / sponsor ID
- 24.DUS.010
- Keywords
- pit and fissure sealants, Preventive Dentistry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 3 Dec 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.
The study group will consist of children aged 7-11 years who are systemically healthy and who apply to the Pediatric Dentistry Clinic of the Faculty of Dentistry, Afyonkarahisar Health Sciences University for routine dental treatment.
In the study, fissure sealants will be applied to the first molars with opposing deep pits and fissures in the same jaw.
The study will involve the application of fissure sealants to the first molars with opposing deep pits and fissures in the same jaw.
It was decided to include a total of 500 teeth from 250 patients in the study, with 250 teeth in each group.
The occlusal surface of each tooth will be dried and etched with 37% phosphoric acid (Eco-Etch; Ivoclar Vivadent, Inc. Schaan, Liechtenstein) and thoroughly rinsed for 30 seconds.
If saliva contamination occurs, the surface will be etched again. The treated tooth will be air-dried for 3 seconds and the tooth in the opposing jaw for 15 seconds. Subsequently, the relevant fissure sealant (Pulpdent, Embrace Wetbond Pit and Fissure Sealant) will be applied to the occlusal surface of each tooth and cured for 20 seconds using a light-curing unit at an intensity of 500 mW/cm².
After restoration, articulation paper will be used to check for any high spots in the occlusion; if found, excess material will be removed using a finishing bur.
Clinical evaluations of marginal integrity, marginal color change, and retention after the liner is placed will be performed at 3, 6, 9, and 12 months using the World Health Organization probe according to the Ryge and Synder criteria.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pit and fissure sealant treatment | Experimental | Other: pit and fissure sealant |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 1. Patients aged 7-11 who applied for dental examination at the Department of Pediatric Dentistry, Faculty of Dentistry, Afyon Health Sciences University.
- 2. Patients must be systemically healthy and have no mental or physical disabilities.
- 3. Permanent first molars must be fully erupted in the mouth, and at least 3 first molars must be indicated for non-invasive fissure sealant application (having narrow, deep fissures prone to decay).
- 4. Permanent first molars to receive fissure sealants must not have hypomineralized areas such as fluorosis or first molar incisal hypomineralization.
- 5. Permanent first molars must not have occlusal or approximal caries.
Key exclusion criteria (4 listed)
- 1. Patients must not be between the ages of 7 and 11. 2. Patients must not be systemically healthy and must have no mental or physical disabilities.
- 3. Patients must have poor oral hygiene. 4. There must be caries in the permanent first molars where fissure sealants will be applied.
- 5. Presence of hypomineralized areas such as fluorosis or first molar hypomineralization on the permanent first molars where fissure sealants will be applied.
- 6. Patients not cooperating with the procedures to be performed. 7. Patients or their parents not wanting to participate in the study.
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 |
|---|---|---|
| pit and fissure sealantFor each tooth to be treated with pit and fissure sealant, phosphoric acid will be used for pre-treatment. One group will be dried with an air-water spray for 3 seconds, while the drying time for the other group of teeth in the opposing jaw will be 15 seconds. | Other | pit and fissure sealant treatment |
Primary outcome
Edge discoloration
Time frame: 3-6-9-12 months
A: No color change between the restoration and the tooth structure B: Localized, mostly removable superficial color change C: Pulpal discoloration
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 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Pit and Fissure Caries (Disorder)
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
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 pit and fissure sealant in people with Pit and Fissure Caries (Disorder) and Pit and Fissure Sealants, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 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 Turkey (Türkiye). 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?
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?
Edge discoloration (time frame: 3-6-9-12 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 3 Dec 2025.