Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional Polishing: A Split-Mouth Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Marmara University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Pit and Fissure Sealant Retention Assessed Using the Modified Simonsen Criteria
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Clinical Performance of Pit and Fissure Sealants Assessed Using Modified USPHS Criteria(At 3, 6, 12, 24, and 36 months after sealant placement)