Dental CariesNCT07763470
Polishing vs Hydrogen Peroxide: Effect on DIAGNOdent Readings in Stained Fissures
A study testing Mechanical Polishing with Fluoride-Free Prophylaxis Paste and 35% Hydrogen Peroxide Application in people with Dental Caries and Occlusal Caries, run by Özlem Erçin Sultanzade at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Occlusal Caries
- What is being tested?
- Mechanical Polishing with Fluoride-Free Prophylaxis Paste and 35% Hydrogen Peroxide Application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of restorations on the involved teeth
- Evident cusp loss, wear, fracture, or cracks on the occlusal surface
- Enamel cracks
- Hypocalcification lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mechanical Polishing and 35% Hydrogen Peroxide Application on DIAGNOdent Measurements in Stained Occlusal Fissures: A Randomized Split-Mouth Clinical Study
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.
Read the 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.
- Conditions
- Dental Caries, Occlusal Caries
- Being tested
- Mechanical Polishing with Fluoride-Free Prophylaxis Paste, 35% Hydrogen Peroxide Application
- Keywords
- DIAGNOdent, Laser Fluorescence, Occlusal Caries, Hydrogen Peroxide, Prophylaxis Paste, Minimally Invasive Dentistry
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Polishing with Fluoride-Free Prophylaxis PasteProcedure or surgery
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 ApplicationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: 35% Hydrogen Peroxide Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
Change in DIAGNOdent score from baseline to after air-water spray cleaning and drying, prior to the assigned surface procedure.
Measured: Baseline and immediately after air-water spray cleaning (single clinical session, same-day)
Between-Group Comparison of DIAGNOdent Score Change
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.
Measured: Baseline and immediately post-procedure (single clinical session, same-day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start1 Mar 2025
- Primary completion1 Oct 2025
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Split-mouth design in which each participant received both interventions, with one procedure randomly assigned to each side of the mouth.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Özlem Erçin Sultanzade
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Özlem Erçin Sultanzade, Istanbul Kent University
- Investigators
- Özlem Erçin Sultanzade, Principal investigator, Istanbul Kent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763470
- Sponsor's protocol ID
- 09.2024.248
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Polishing and 35% Hydrogen Peroxide Application on DIAGNOdent Measurements in Stained Occlusal Fissures: A Randomized Split-Mouth Clinical Study
- ClinicalTrials.gov ID
- NCT07763470
- Acronym / sponsor ID
- 09.2024.248
- Conditions
- Dental Caries, Occlusal Caries
- Keywords
- DIAGNOdent, Laser Fluorescence, Occlusal Caries, Hydrogen Peroxide, Prophylaxis Paste, Minimally Invasive Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Özlem Erçin SultanzadeUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design in which each participant received both interventions, with one procedure randomly assigned to each side of the mouth.
| Arm | Type | Receives |
|---|---|---|
| Mechanical Polishing | Experimental | Procedure: 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 Peroxide | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of restorations on the involved teeth
- Evident cusp loss, wear, fracture, or cracks on the occlusal surface
- Enamel cracks
- Hypocalcification lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Polishing with Fluoride-Free Prophylaxis PasteApplication 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. | Procedure or surgery | Mechanical Polishing |
| 35% Hydrogen Peroxide ApplicationApplication 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. | Procedure or surgery | 35% Hydrogen Peroxide |
Primary outcome
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.
2 secondary outcomes
DIAGNOdent Score Change After Air-Water Spray Cleaning
Time frame: Baseline and immediately after air-water spray cleaning (single clinical session, same-day)
Between-Group Comparison of DIAGNOdent Score Change
Time frame: Baseline and immediately post-procedure (single clinical session, same-day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem Erçin Sultanzade principal investigator
Istanbul Kent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Polishing with Fluoride-Free Prophylaxis Paste and 35% Hydrogen Peroxide Application in people with Dental Caries and Occlusal Caries, run by Özlem Erçin Sultanzade at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DIAGNOdent Score (time frame: Measured at baseline and immediately after the assigned surface procedure (within a single clinical session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.