Effect of Mechanical Polishing and 35% Hydrogen Peroxide Application on DIAGNOdent Measurements in Stained Occlusal Fissures: A Randomized Split-Mouth Clinical Study
| Registry | NCT07763470 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: single, diagnostic |
| Enrollment | 25 (Actual) |
| Sponsor | Özlem Erçin Sultanzade (Other) |
| Conditions | Dental Caries, Occlusal Caries |
| Interventions | Mechanical Polishing with Fluoride-Free Prophylaxis Paste, 35% Hydrogen Peroxide Application (Procedure) |
| Dates | start 2025-03-01, primary completion 2025-10-01, completion 2026-05-01, first posted 2026-08-13, last updated 2026-08-13 |
| Locations | 1 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
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Mechanical Polishing | Experimental | Procedure: Mechanical Polishing with Fluoride-Free Prophylaxis Paste | Fluoride-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 Peroxide | Experimental | Procedure: 35% Hydrogen Peroxide Application | In-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. |
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
| Facility | City | Country | Status |
|---|---|---|---|
| İstanbul Kent University | Istanbul | Turkey (Türkiye) |