Black StainingNCT07730658
Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children
A study testing Guided Biofilm Therapy with erythritol and Conventional Polishing in people with Black Staining, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized clinical trial is to compare the effect of erythritol air-polishing and conventional polishing following ultrasonic scaling on the relapse of chromogenic tooth staining in children aged 4-13 years attending the Pediatric Dentistry Clinic of Marmara University Faculty of Dentistry for… Read more about this study
- Who is it for?
- Ages 4 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Black Staining
- What is being tested?
- Guided Biofilm Therapy with erythritol and Conventional Polishing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-13 years.
- Absence of oral diseases, including gingivitis and oral mucosal diseases.
- No orthodontic appliances.
- No history of iron supplementation or professional fluoride treatment within the previous 3 months.
- Systemically healthy children.
Who cannot join
- Presence of oral diseases, including periodontitis, salivary gland diseases, or oral mucosal diseases.
- History of autoimmune disease.
- Antibiotic use within the previous 3 months.
- Consumption of tannin-containing beverages (e.g., tea, coffee, or similar beverages) within the previous 1 month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi
Istanbul, MALTEPE, 34854
Betul Sen Yavuz, +90 539 988 76 46, dtbetulsen@gmail.com
About this study
Official title: Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children: A Randomized Clinical Trial
The goal of this randomized clinical trial is to compare the effect of erythritol air-polishing and conventional polishing following ultrasonic scaling on the relapse of chromogenic tooth staining in children aged 4-13 years attending the Pediatric Dentistry Clinic of Marmara University Faculty of Dentistry for routine dental examination.
The main questions this study aims to answer are:
Read more
- Does erythritol air-polishing reduce the relapse of chromogenic tooth staining compared with conventional polishing following ultrasonic scaling?
- Is there a difference in the time to relapse of chromogenic tooth staining between the two polishing techniques?
Researchers will compare conventional polishing (prophylaxis paste and a polishing brush) following ultrasonic scaling with erythritol air-polishing performed using the EMS air-polishing device following ultrasonic scaling to determine whether one method is more effective in preventing or delaying the relapse of chromogenic tooth staining.
Read the detailed description
Participants will:
Undergo a routine oral examination. Receive professional removal of chromogenic tooth staining using ultrasonic scaling.
Be randomly assigned to receive either conventional polishing with prophylaxis paste and a polishing brush or erythritol air-polishing using the EMS air-polishing device.
Attend follow-up visits to assess the recurrence of chromogenic tooth staining over time.
Chromogenic tooth staining will be assessed using the Qraycam.
- Conditions
- Black Staining
- Being tested
- Guided Biofilm Therapy with erythritol, Conventional Polishing
- Keywords
- guided biofilm therapy, polishing, tooth discoloration, air polishing, ultrasonic scaling
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Biofilm Therapy with erythritolDevice
Description: Participants assigned to Group 1 will receive professional removal of chromogenic tooth staining using ultrasonic scaling followed by erythritol air-polishing with the EMS air-polishing device, guided by a plaque-disclosing agent. At the end of the procedure, the investigator will record the treatment time, apply the plaque-disclosing agent, obtain intraoral photographs, and assess chromogenic tooth staining using the Qraycam.
Conventional PolishingDevice
Participants will undergo professional tooth cleaning using the ultrasonic scaler of the EMS device. The tooth surfaces will then be polished using a polishing brush and prophylaxis paste.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Erythritol Air-Polishing Using the EMS Air-Polishing Device) | Active comparator | Not described Receives: Device: Guided Biofilm Therapy with erythritol |
| Group 2 (Conventional Polishing Using Prophylaxis Paste and a Polishing Brush) | Active comparator | Not described Receives: Device: Conventional Polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Black Stain Score
Black Stain Classification (Gasparetto et al., 2003) Score Description Clinical Characteristics 0 None No black pigmentation on the tooth surface.
- Mild Pigmented dots or thin pigmented lines parallel to the gingival margin that are not continuous.
- Moderate Continuous pigmented lines o extending over up to one-half of the cervical third of the tooth surface.
- Severe Pigmentation extending over more than one-half of the cervical third of the tooth surface.
Black Stain Classification (Zerman et al., 2024) Score Description A Pigmented lines or dots present only on the buccal surface. B Pigmented lines or dots present on both the buccal and lingual surfaces. C Pigmented lines or dots associated with dental caries. D Recurrent pigmented lines or dots.
Measured: Baseline, immediately after polishing, 1 month, 2 months, 3 months, and 6 months
Participant Feedback
Pain perception during the procedure will be assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "hurts worst." Higher scores indicate greater pain intensity (worse outcome).
Measured: Periprocedural
Time Session
The duration of treatment is noted and compared between groups
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start7 Jul 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Black StainingStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730658
- Sponsor's protocol ID
- GBTvschromogenic
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07730658
- Acronym / sponsor ID
- GBTvschromogenic
- Conditions
- Black Staining
- Keywords
- guided biofilm therapy, polishing, tooth discoloration, air polishing, ultrasonic scaling
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 7 Jul 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 28 Jul 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.
The goal of this randomized clinical trial is to compare the effect of erythritol air-polishing and conventional polishing following ultrasonic scaling on the relapse of chromogenic tooth staining in children aged 4-13 years attending the Pediatric Dentistry Clinic of Marmara University Faculty of Dentistry for routine dental examination.
The main questions this study aims to answer are:
- Does erythritol air-polishing reduce the relapse of chromogenic tooth staining compared with conventional polishing following ultrasonic scaling?
- Is there a difference in the time to relapse of chromogenic tooth staining between the two polishing techniques?
Researchers will compare conventional polishing (prophylaxis paste and a polishing brush) following ultrasonic scaling with erythritol air-polishing performed using the EMS air-polishing device following ultrasonic scaling to determine whether one method is more effective in preventing or delaying the relapse of chromogenic tooth staining.
Detailed description
Participants will:
Undergo a routine oral examination. Receive professional removal of chromogenic tooth staining using ultrasonic scaling.
Be randomly assigned to receive either conventional polishing with prophylaxis paste and a polishing brush or erythritol air-polishing using the EMS air-polishing device.
Attend follow-up visits to assess the recurrence of chromogenic tooth staining over time.
Chromogenic tooth staining will be assessed using the Qraycam.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Erythritol Air-Polishing Using the EMS Air-Polishing Device) | Active comparator | Device: Guided Biofilm Therapy with erythritol |
| Group 2 (Conventional Polishing Using Prophylaxis Paste and a Polishing Brush) | Active comparator | Device: Conventional Polishing |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 4-13 years.
- Absence of oral diseases, including gingivitis and oral mucosal diseases.
- No orthodontic appliances.
- No history of iron supplementation or professional fluoride treatment within the previous 3 months.
- Systemically healthy children.
Key exclusion criteria (4 listed)
- Presence of oral diseases, including periodontitis, salivary gland diseases, or oral mucosal diseases.
- History of autoimmune disease.
- Antibiotic use within the previous 3 months.
- Consumption of tannin-containing beverages (e.g., tea, coffee, or similar beverages) within the previous 1 month.
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 |
|---|---|---|
| Guided Biofilm Therapy with erythritolDescription: Participants assigned to Group 1 will receive professional removal of chromogenic tooth staining using ultrasonic scaling followed by erythritol air-polishing with the EMS air-polishing device, guided by a plaque-disclosing agent. At the end of the procedure, the investigator will record the treatment time, apply the plaque-disclosing agent, obtain intraoral photographs, and assess chromogenic tooth staining using the Qraycam. | Device | Group 1 (Erythritol Air-Polishing Using the EMS Air-Polishing Device) |
| Conventional PolishingParticipants will undergo professional tooth cleaning using the ultrasonic scaler of the EMS device. The tooth surfaces will then be polished using a polishing brush and prophylaxis paste. | Device | Group 2 (Conventional Polishing Using Prophylaxis Paste and a Polishing Brush) |
Primary outcome
Black Stain Score
Time frame: Baseline, immediately after polishing, 1 month, 2 months, 3 months, and 6 months
Black Stain Classification (Gasparetto et al., 2003) Score Description Clinical Characteristics 0 None No black pigmentation on the tooth surface. 1. Mild Pigmented dots or thin pigmented lines parallel to the gingival margin that are not continuous. 2. Moderate Continuous pigmented lines o extending over up to one-half of the cervical third of the tooth surface. 3. Severe Pigmentation extending over more than one-half of the cervical third of the tooth surface. Black Stain Classification (Zerman et al., 2024) Score Description A Pigmented lines or dots present only on the buccal surface. B Pigmented lines or dots present on both the buccal and lingual surfaces. C Pigmented lines or dots associated with dental caries. D Recurrent pigmented lines or dots.
Participant Feedback
Time frame: Periprocedural
Pain perception during the procedure will be assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "hurts worst." Higher scores indicate greater pain intensity (worse outcome).
Time Session
Time frame: Periprocedural
The duration of treatment is noted and compared between groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi
Istanbul, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Biofilm Therapy with erythritol and Conventional Polishing in people with Black Staining, run by Marmara University 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 5 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: opening soon, as of the sponsor's last update on 28 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Black Stain Score (time frame: Baseline, immediately after polishing, 1 month, 2 months, 3 months, and 6 months). The study lists 3 primary outcomes in all. 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 28 Jul 2026.