Pit and Fissure Sealant RetentionNCT07725133
Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing
A study testing Device: Guided Biofilm Therapy with erythritol and Device: Conventional Polishing in people with Pit and Fissure Sealant Retention and Dental Caries, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This randomized split-mouth clinical trial will compare two methods of occlusal surface cleaning before pit and fissure sealant placement in children aged 6-10 years. In each participant, eligible permanent first molars will receive either erythritol-based Guided Biofilm Therapy or conventional rotary-brush polishing… Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pit and Fissure Sealant Retention, Dental Caries
- What is being tested?
- Device: Guided Biofilm Therapy with erythritol and Device: Conventional Polishing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2026to 20 Oct 2029
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-10 years presenting to the Department of Pediatric Dentistry, Marmara University Faculty of Dentistry, for routine dental treatment.
- Systemically healthy individuals classified as ASA I.
- Children who are cooperative and able to maintain communication throughout the clinical procedure.
- Presence of at least two comparable permanent first molars with unrestored occlusal surfaces that are either caries-free or have initial lesions limited to the pit and fissure level.
Who cannot join
- Individuals with systemic diseases (e.g., diabetes, epilepsy, cardiovascular diseases), classified as ASA II or higher.
- Individuals who have used antibiotics, anti-inflammatory drugs, or immunosuppressive medications within the past 3 months.
- Children who are unable to communicate due to emotional, psychological, or developmental disorders.
- Individuals with previously placed pit and fissure sealants on their permanent first molars.
- Presence of deep carious lesions, restorations, or structural defects such as molar-incisor hypomineralization (MIH) in the teeth planned for inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing: A Split-Mouth Randomized Clinical Trial
This randomized split-mouth clinical trial will compare two methods of occlusal surface cleaning before pit and fissure sealant placement in children aged 6-10 years.
In each participant, eligible permanent first molars will receive either erythritol-based Guided Biofilm Therapy or conventional rotary-brush polishing before phosphoric acid etching and placement of the same resin-based sealant. Each child will receive both interventions on opposite sides of the mouth.
The sealants will be followed for up to 36 months to determine whether the surface-cleaning method influences sealant retention and clinical performance. Procedure-related discomfort will also be compared between the two methods.
Read the detailed description
Pit and fissure sealants are used to prevent occlusal caries in permanent molars. Their clinical effectiveness depends largely on adequate penetration, marginal integrity, and long-term retention. Removal of plaque, pellicle, and debris from deep occlusal fissures before sealant application may therefore influence treatment success.
Conventional prophylaxis with a rotary brush is routinely used to clean the occlusal surface before acid etching. Guided Biofilm Therapy uses an air-polishing device with low-abrasive erythritol powder to remove biofilm. Due to its small particle size and low abrasiveness, erythritol-based air polishing may provide effective cleaning of occlusal fissures while minimizing damage to dental tissues. However, evidence regarding its effect on the long-term retention of pit and fissure sealants in children remains limited.
Systemically healthy children aged 6-10 years attending the Department of Pediatric Dentistry at Marmara University Faculty of Dentistry for routine dental treatment will be screened. Participants must have at least two comparable permanent first molars suitable for sealant placement. Teeth with previous restorations or sealants, advanced caries, molar-incisor hypomineralization, or other structural defects will be excluded. Approximately 80 children, corresponding to 160 permanent first molars, are planned to be enrolled.
A randomized split-mouth design will be used. For each participant, the right or left side will be allocated to one of the two surface-cleaning protocols by random selection, and the opposite side will receive the alternative protocol. Because both interventions are applied within the same participant, individual factors that may affect sealant retention can be controlled.
For teeth allocated to the Guided Biofilm Therapy protocol, the occlusal surface will be cleaned using an air-polishing device and an ultra-fine powder containing approximately 99% erythritol with a particle size of approximately 14 µm. The powder will be applied for 5 seconds from a distance of approximately 2 mm under suction.
For teeth allocated to the conventional protocol, the occlusal surface will be cleaned using a rotary prophylaxis brush. After the assigned cleaning procedure, all teeth will be etched with 37% phosphoric acid for 15 seconds. The surfaces will then be rinsed and dried, and a resin-based, fluoride-releasing pit and fissure sealant will be applied and light-cured for 15 seconds.
All interventions will be performed by the same trained clinician in accordance with the manufacturers' instructions. The procedures assigned to the two sides will be performed at separate appointments, with an interval of at least one week.
Participant age and sex will be recorded at baseline. Dental caries experience will be assessed using the dmft/DMFT index as part of the routine oral examination. Immediately after each procedure, the child's perceived pain or discomfort will be recorded using the Wong-Baker Faces Pain Rating Scale.
Clinical examinations will be conducted at 3, 6, 12, 24, and 36 months by an evaluator who is blinded to the surface-cleaning method used for each tooth. Sealant retention will be assessed using the modified Simonsen criteria and the Tonn and Ryge criteria. Additional clinical characteristics, including marginal adaptation, secondary caries, anatomical form, surface roughness, marginal discoloration, color match, and postoperative sensitivity, will be assessed using modified United States Public Health Service criteria.
When partial or complete sealant loss is detected, the sealant will be replaced according to routine clinical practice to prevent the tooth from remaining unprotected. The affected tooth and participant will then be considered to have reached the study endpoint and will be withdrawn from further study follow-up.
- Conditions
- Pit and Fissure Sealant Retention, Dental Caries
- Being tested
- Device: Guided Biofilm Therapy with erythritol, Device: Conventional Polishing
- Keywords
- guided biofilm therapy, airflowing, fissure sealant
- Medical subject headings
- Van der Woude syndrome, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Guided Biofilm Therapy with erythritolDevice
Permanent first molars assigned to Group 1 will receive occlusal surface cleaning using the AIRFLOW® Prophylaxis Master device (EMS, Switzerland) with AIRFLOW® Plus Powder containing approximately 99% erythritol and a particle size of approximately 14 μm. The powder will be applied for 5 seconds from a distance of approximately 2 mm under suction. The tooth surface will then be etched with 37% phosphoric acid for 15 seconds, followed by the application of Clinpro™ Sealant (3M ESPE, USA), which will be light-cured for 15 seconds.
Device: Conventional PolishingDevice
Permanent first molars assigned to Group 2 will receive occlusal surface cleaning using conventional polishing with a rotary prophylaxis brush. The tooth surface will then be etched with 37% phosphoric acid for 15 seconds, followed by the application of Clinpro™ Sealant (3M ESPE, USA), which will be light-cured for 15 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Guided Biofilm Therapy + Phosphoric Acid Etching + Pit and Fissure Sealant) | Active comparator | Not described Receives: Device: Device: Guided Biofilm Therapy with erythritol |
| Group 2: Conventional Polishing + Phosphoric Acid Etching + Pit and Fissure Sealant | Active comparator | Not described Receives: Device: Device: Conventional Polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pit and Fissure Sealant Retention Assessed Using the Modified Simonsen Criteria
Pit and fissure sealant retention will be clinically assessed at the tooth level using the Modified Simonsen Criteria. Score 0 indicates no sealant loss and no caries; Score 1 indicates partial sealant loss without caries; Score 2 indicates partial sealant loss with caries; Score 3 indicates complete sealant loss without caries; and Score 4 indicates complete sealant loss with caries. A score of 1, 2, 3, or 4 at any follow-up visit will be considered retention failure and achievement of the primary endpoint.
Measured: At 3, 6, 12, 24, and 36 months after sealant placement
Secondary outcomes (1)
Clinical Performance of Pit and Fissure Sealants Assessed Using Modified USPHS Criteria
The clinical performance of the pit and fissure sealants will be evaluated at the tooth level using the Modified United States Public Health Service criteria. The evaluated domains will include marginal adaptation, secondary caries, anatomical form, surface roughness, color match, marginal discoloration, and postoperative sensitivity. Each domain will be rated as Alpha, Bravo, or Charlie, as applicable, with Alpha indicating optimal clinical performance and Charlie indicating clinically unacceptable performance or the need for intervention.
Measured: At 3, 6, 12, 24, and 36 months after sealant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion20 Aug 2029 (estimated)
- Study completion20 Oct 2029 (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 Sealant RetentionStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725133
- Sponsor's protocol ID
- GBTvsConventionalPolishing
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing: A Split-Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07725133
- Acronym / sponsor ID
- GBTvsConventionalPolishing
- Conditions
- Pit and Fissure Sealant Retention, Dental Caries
- Keywords
- guided biofilm therapy, airflowing, fissure sealant
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 20 Aug 2029 (estimated)
- Study completion
- 20 Oct 2029 (estimated)
- First posted
- 24 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.
This randomized split-mouth clinical trial will compare two methods of occlusal surface cleaning before pit and fissure sealant placement in children aged 6-10 years.
In each participant, eligible permanent first molars will receive either erythritol-based Guided Biofilm Therapy or conventional rotary-brush polishing before phosphoric acid etching and placement of the same resin-based sealant. Each child will receive both interventions on opposite sides of the mouth.
The sealants will be followed for up to 36 months to determine whether the surface-cleaning method influences sealant retention and clinical performance. Procedure-related discomfort will also be compared between the two methods.
Detailed description
Pit and fissure sealants are used to prevent occlusal caries in permanent molars. Their clinical effectiveness depends largely on adequate penetration, marginal integrity, and long-term retention. Removal of plaque, pellicle, and debris from deep occlusal fissures before sealant application may therefore influence treatment success.
Conventional prophylaxis with a rotary brush is routinely used to clean the occlusal surface before acid etching. Guided Biofilm Therapy uses an air-polishing device with low-abrasive erythritol powder to remove biofilm. Due to its small particle size and low abrasiveness, erythritol-based air polishing may provide effective cleaning of occlusal fissures while minimizing damage to dental tissues. However, evidence regarding its effect on the long-term retention of pit and fissure sealants in children remains limited.
Systemically healthy children aged 6-10 years attending the Department of Pediatric Dentistry at Marmara University Faculty of Dentistry for routine dental treatment will be screened. Participants must have at least two comparable permanent first molars suitable for sealant placement. Teeth with previous restorations or sealants, advanced caries, molar-incisor hypomineralization, or other structural defects will be excluded. Approximately 80 children, corresponding to 160 permanent first molars, are planned to be enrolled.
A randomized split-mouth design will be used. For each participant, the right or left side will be allocated to one of the two surface-cleaning protocols by random selection, and the opposite side will receive the alternative protocol. Because both interventions are applied within the same participant, individual factors that may affect sealant retention can be controlled.
For teeth allocated to the Guided Biofilm Therapy protocol, the occlusal surface will be cleaned using an air-polishing device and an ultra-fine powder containing approximately 99% erythritol with a particle size of approximately 14 µm. The powder will be applied for 5 seconds from a distance of approximately 2 mm under suction.
For teeth allocated to the conventional protocol, the occlusal surface will be cleaned using a rotary prophylaxis brush. After the assigned cleaning procedure, all teeth will be etched with 37% phosphoric acid for 15 seconds. The surfaces will then be rinsed and dried, and a resin-based, fluoride-releasing pit and fissure sealant will be applied and light-cured for 15 seconds.
All interventions will be performed by the same trained clinician in accordance with the manufacturers' instructions. The procedures assigned to the two sides will be performed at separate appointments, with an interval of at least one week.
Participant age and sex will be recorded at baseline. Dental caries experience will be assessed using the dmft/DMFT index as part of the routine oral examination. Immediately after each procedure, the child's perceived pain or discomfort will be recorded using the Wong-Baker Faces Pain Rating Scale.
Clinical examinations will be conducted at 3, 6, 12, 24, and 36 months by an evaluator who is blinded to the surface-cleaning method used for each tooth. Sealant retention will be assessed using the modified Simonsen criteria and the Tonn and Ryge criteria. Additional clinical characteristics, including marginal adaptation, secondary caries, anatomical form, surface roughness, marginal discoloration, color match, and postoperative sensitivity, will be assessed using modified United States Public Health Service criteria.
When partial or complete sealant loss is detected, the sealant will be replaced according to routine clinical practice to prevent the tooth from remaining unprotected. The affected tooth and participant will then be considered to have reached the study endpoint and will be withdrawn from further study follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Guided Biofilm Therapy + Phosphoric Acid Etching + Pit and Fissure Sealant) | Active comparator | Device: Device: Guided Biofilm Therapy with erythritol |
| Group 2: Conventional Polishing + Phosphoric Acid Etching + Pit and Fissure Sealant | Active comparator | Device: Device: Conventional Polishing |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-10 years presenting to the Department of Pediatric Dentistry, Marmara University Faculty of Dentistry, for routine dental treatment.
- Systemically healthy individuals classified as ASA I.
- Children who are cooperative and able to maintain communication throughout the clinical procedure.
- Presence of at least two comparable permanent first molars with unrestored occlusal surfaces that are either caries-free or have initial lesions limited to the pit and fissure level.
Key exclusion criteria (5 listed)
- Individuals with systemic diseases (e.g., diabetes, epilepsy, cardiovascular diseases), classified as ASA II or higher.
- Individuals who have used antibiotics, anti-inflammatory drugs, or immunosuppressive medications within the past 3 months.
- Children who are unable to communicate due to emotional, psychological, or developmental disorders.
- Individuals with previously placed pit and fissure sealants on their permanent first molars.
- Presence of deep carious lesions, restorations, or structural defects such as molar-incisor hypomineralization (MIH) in the teeth planned for inclusion 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 |
|---|---|---|
| Device: Guided Biofilm Therapy with erythritolPermanent first molars assigned to Group 1 will receive occlusal surface cleaning using the AIRFLOW® Prophylaxis Master device (EMS, Switzerland) with AIRFLOW® Plus Powder containing approximately 99% erythritol and a particle size of approximately 14 μm. The powder will be applied for 5 seconds from a distance of approximately 2 mm under suction. The tooth surface will then be etched with 37% phosphoric acid for 15 seconds, followed by the application of Clinpro™ Sealant (3M ESPE, USA), which will be light-cured for 15 seconds. | Device | Group 1 (Guided Biofilm Therapy + Phosphoric Acid Etching + Pit and Fissure Sealant) |
| Device: Conventional PolishingPermanent first molars assigned to Group 2 will receive occlusal surface cleaning using conventional polishing with a rotary prophylaxis brush. The tooth surface will then be etched with 37% phosphoric acid for 15 seconds, followed by the application of Clinpro™ Sealant (3M ESPE, USA), which will be light-cured for 15 seconds. | Device | Group 2: Conventional Polishing + Phosphoric Acid Etching + Pit and Fissure Sealant |
Primary outcome
Pit and Fissure Sealant Retention Assessed Using the Modified Simonsen Criteria
Time frame: At 3, 6, 12, 24, and 36 months after sealant placement
Pit and fissure sealant retention will be clinically assessed at the tooth level using the Modified Simonsen Criteria. Score 0 indicates no sealant loss and no caries; Score 1 indicates partial sealant loss without caries; Score 2 indicates partial sealant loss with caries; Score 3 indicates complete sealant loss without caries; and Score 4 indicates complete sealant loss with caries. A score of 1, 2, 3, or 4 at any follow-up visit will be considered retention failure and achievement of the primary endpoint.
1 secondary outcome
Clinical Performance of Pit and Fissure Sealants Assessed Using Modified USPHS Criteria
Time frame: At 3, 6, 12, 24, and 36 months after sealant placement
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 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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
Pits and Fissure Sealants
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.
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 Device: Guided Biofilm Therapy with erythritol and Device: Conventional Polishing in people with Pit and Fissure Sealant Retention and Dental Caries, run by Marmara 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 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: opening soon, as of the sponsor's last update on 24 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 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?
Pit and Fissure Sealant Retention Assessed Using the Modified Simonsen Criteria (time frame: At 3, 6, 12, 24, and 36 months after sealant placement). 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 24 Jul 2026.