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NCT Number: NCT07763470

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

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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Key information

Conditions

Dental Caries Occlusal Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Kent University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in DIAGNOdent Score

    Time frame: 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

  1. DIAGNOdent Score Change After Air-Water Spray Cleaning

    Time frame: 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.

  2. Between-Group Comparison of DIAGNOdent Score Change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Özlem Erçin Sultanzade

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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