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

NCT07763470 | Completed

• 1 other identifier: 09.2024.248
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries; Occlusal Caries

Keywords

DIAGNOdent; Laser Fluorescence; Occlusal Caries; Hydrogen Peroxide; Prophylaxis Paste; Minimally Invasive Dentistry

Outcome Measures

Primary Outcomes (1)

• Change in DIAGNOdent Score

  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.

  Measured at baseline and immediately after the assigned surface procedure (within a single clinical session)

Secondary Outcomes (2)

• DIAGNOdent Score Change After Air-Water Spray Cleaning

  Baseline and immediately after air-water spray cleaning (single clinical session, same-day)

• Between-Group Comparison of DIAGNOdent Score Change

  Baseline and immediately post-procedure (single clinical session, same-day)

Study Arms (2)

Mechanical Polishing

EXPERIMENTAL

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.

Procedure: Mechanical Polishing with Fluoride-Free Prophylaxis Paste

35% Hydrogen Peroxide

EXPERIMENTAL

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.

Procedure: 35% Hydrogen Peroxide Application

Interventions

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.

Mechanical Polishing

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.

35% Hydrogen Peroxide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Özlem Erçin Sultanzade: lead

Study Sites (1)

İstanbul Kent University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Özlem Erçin Sultanzade

  Istanbul Kent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiograph assessor was blinded to the assigned surface procedure.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Split-mouth design in which each participant received both interventions, with one procedure randomly assigned to each side of the mouth.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 13, 2026
• Study Start: March 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: May 1, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)