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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).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

Turkey (Türkiye)1 site
  • Marmara University

    Istanbul, Maltepe, 34384

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07725133
Study groupRoleWhat they receive
Group 1 (Guided Biofilm Therapy + Phosphoric Acid Etching + Pit and Fissure Sealant)Active comparatorNot described
Receives: Device: Device: Guided Biofilm Therapy with erythritol
Group 2: Conventional Polishing + Phosphoric Acid Etching + Pit and Fissure SealantActive comparatorNot described
Receives: Device: Device: Conventional Polishing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted24 Jul 2026
  2. Study start20 Jul 2026 (estimated)
  3. Primary completion20 Aug 2029 (estimated)
  4. Study completion20 Oct 2029 (estimated)

Resources

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)
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

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.

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