Polishing vs Hydrogen Peroxide: Effect on DIAGNOdent Readings in Stained Fissures

NCT07763470 — Not applicable, Completed, 25 participants, Özlem Erçin Sultanzade

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Effect of Mechanical Polishing and 35% Hydrogen Peroxide Application on DIAGNOdent Measurements in Stained Occlusal Fissures: A Randomized Split-Mouth Clinical Study

RegistryNCT07763470
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: single, diagnostic
Enrollment25 (Actual)
SponsorÖzlem Erçin Sultanzade (Other)
ConditionsDental Caries, Occlusal Caries
InterventionsMechanical Polishing with Fluoride-Free Prophylaxis Paste, 35% Hydrogen Peroxide Application (Procedure)
Datesstart 2025-03-01, primary completion 2025-10-01, completion 2026-05-01, first posted 2026-08-13, last updated 2026-08-13
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Dental Caries All trials for Occlusal Caries All trials of Mechanical Polishing with Fluoride-Free Prophylaxis Paste All trials of 35% Hydrogen Peroxide Application

-Summary

This study compared two methods of cleaning stained pits and grooves (fissures) on the chewing surfaces of back teeth before measuring them with a laser fluorescence device (DIAGNOdent), which is used to help detect early tooth decay. In the same patients, one side of the mouth was treated with mechanical polishing using a prophylaxis paste, while the other side was treated with a 35% hydrogen peroxide gel. The study measured whether either cleaning method changed the device's readings, and if so, by how much. The results showed that the readings increased after both procedures, but the increase was larger after polishing than after hydrogen peroxide application. These findings may help clinicians better interpret DIAGNOdent readings after cleaning stained teeth.

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+Detailed description

In this randomized, single-blind, split-mouth clinical study, 126 posterior teeth from 24 adult participants with clinically visible occlusal fissure staining were evaluated. For each participant, opposing jaws were randomly assigned to receive either mechanical polishing with a fluoride-free prophylaxis paste (30 seconds) or a 35% hydrogen peroxide gel (15 minutes). DIAGNOdent Pen laser fluorescence measurements were recorded at three time points: baseline, after air-water spray cleaning and drying, and after the assigned surface procedure. Digital bite-wing radiographs were obtained as a non-invasive clinical reference. Within-group comparisons were analyzed using the Wilcoxon signed-rank test, and between-protocol comparisons were analyzed using a linear mixed-effects model with patient as a random effect and surface procedure as a fixed effect.

+Arms and interventions

ArmTypeInterventionsDescription
Mechanical PolishingExperimentalProcedure: Mechanical Polishing with Fluoride-Free Prophylaxis PasteFluoride-free prophylaxis paste (Cleanic, Kerr, Salerno, Italy) applied to the fissure area using a polishing brush attached to a micromotor at 10,000 rpm for 30 seconds with light pressure using circular movements, followed by water spray rinse and air drying.
35% Hydrogen PeroxideExperimentalProcedure: 35% Hydrogen Peroxide ApplicationIn-office bleaching agent containing 35% hydrogen peroxide (Whiteness HP, FGM Dental, Brazil), prepared per manufacturer's instructions (3 drops peroxide, 1 drop thickener), applied to completely cover stained fissure areas for 15 minutes, then aspirated and rinsed with water and air dried.
  • Mechanical Polishing with Fluoride-Free Prophylaxis Paste (Procedure): Application of a fluoride-free prophylaxis paste (Cleanic, Kerr, Salerno, Italy) to the occlusal fissure area using a polishing brush attached to a micromotor operating at 10,000 rpm, for 30 seconds with light pressure using circular movements, followed by water spray rinse and air drying.
  • 35% Hydrogen Peroxide Application (Procedure): Application of an in-office bleaching agent containing 35% hydrogen peroxide (Whiteness HP, FGM Dental, Brazil), prepared per manufacturer's instructions (3 drops peroxide, 1 drop thickener), covering the stained fissure areas for 15 minutes, followed by aspiration, water rinse, and air drying.

+Outcome measures

Primary outcomes

  • Change in DIAGNOdent Score [Measured at baseline and immediately after the assigned surface procedure (within a single clinical session)]: Change in DIAGNOdent Pen laser fluorescence score, calculated as the post-surface-procedure value minus the baseline value, measured at the deepest point of the occlusal fissure. The DIAGNOdent Pen (KaVo, Biberach, Germany) scale ranges from 0 to 99, with higher scores indicating greater fluorescence and a higher likelihood of caries-related or stain-related tissue changes.

Secondary outcomes

  • DIAGNOdent Score Change After Air-Water Spray Cleaning [Baseline and immediately after air-water spray cleaning (single clinical session, same-day)]: Change in DIAGNOdent score from baseline to after air-water spray cleaning and drying, prior to the assigned surface procedure.
  • Between-Group Comparison of DIAGNOdent Score Change [Baseline and immediately post-procedure (single clinical session, same-day)]: Comparison of the post-procedure minus baseline DIAGNOdent score change between the mechanical polishing group and the 35% hydrogen peroxide group, analyzed using a linear mixed-effects model.

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* Age between 18 and 65 years
* Clinically visible staining in the fissures of at least two permanent posterior teeth
* Absence of cavitation, restoration, or sensitivity in the involved teeth

Exclusion Criteria:

* Presence of restorations on the involved teeth
* Evident cusp loss, wear, fracture, or cracks on the occlusal surface
* Enamel cracks
* Hypocalcification lesions

+Locations (1)

FacilityCityCountryStatus
İstanbul Kent UniversityIstanbulTurkey (Türkiye)

+Investigators

  • Özlem Erçin Sultanzade, Principal investigator, Istanbul Kent University