Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing

NCT07725133 | Not Yet Recruiting

• 1 other identifier: GBTvsConventionalPolishing
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pit and Fissure Sealant Retention; Dental Caries

Keywords

guided biofilm therapy; airflowing; fissure sealant

Outcome Measures

Primary Outcomes (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.

  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

  At 3, 6, 12, 24, and 36 months after sealant placement

Other Outcomes (1)

• Fissure Sealant Retention According to the Tonn and Ryge Criteria

  At 3, 6, 12, 24, and 36 months after sealant placement

Study Arms (2)

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

Interventions

Device: Guided Biofilm Therapy with erythritol DEVICE

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.

Group 1 (Guided Biofilm Therapy + Phosphoric Acid Etching + Pit and Fissure Sealant)

Device: Conventional Polishing DEVICE

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.

Group 2: Conventional Polishing + Phosphoric Acid Etching + Pit and Fissure Sealant

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34384, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Van der Woude syndrome; Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): August 20, 2029
• Study Completion (Estimated): October 20, 2029
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

TU (1)