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

NCT07725133 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-24

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2029-08-20
Completion
2029-10-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725133 on ClinicalTrials.gov