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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries; Pit and Fissure Sealant Retention
• Intervention / Treatment: Device: Device: Guided Biofilm Therapy with erythritol; Device: Device: Conventional Polishing

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Maltepe
    • Istanbul, Maltepe, Turkey (Türkiye), 34384
      • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 (Guided Biofilm Therapy + Phosphoric Acid Etching + Pit and Fissure Sealant)	Device: Device: Guided Biofilm Therapy with erythritol; 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.
Active Comparator: Group 2: Conventional Polishing + Phosphoric Acid Etching + Pit and Fissure Sealant	Device: Device: Conventional Polishing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 3, 6, 12, 24, and 36 months after sealant placement

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fissure Sealant Retention According to the Tonn and Ryge Criteria	Pit and fissure sealant retention will be clinically assessed using the Tonn and Ryge criteria. Score 0 indicates complete retention, with the sealant material completely present on the occlusal surface; Score 1 indicates partial loss or the presence of cracks; and Score 2 indicates complete loss of the sealant. Higher scores indicate poorer sealant retention.	At 3, 6, 12, 24, and 36 months after sealant placement

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): August 20, 2029
• Study Completion (Estimated): October 20, 2029

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: fissure sealant; guided biofilm therapy; airflowing
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries; Van der Woude syndrome
• Other Study ID Numbers: GBTvsConventionalPolishing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No