An interventional study of Guided Biofilm Therapy with erythritol and Conventional Polishing in Black Staining, sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Marmara University · Not applicable, Interventional, and Basic science
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:
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.
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.
105 studies on the registry are indexed under Tooth Discoloration; 19 are open to participants now.
This study's planned enrollment of 56 is above the median of 48 across 97 interventional studies indexed under Tooth Discoloration.
Browse Tooth Discoloration studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Guided Biofilm Therapy with erythritol
Device: Conventional Polishing
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.
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.
Black Stain Score
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.
Time frame: 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).
Time frame: Periprocedural
Time Session
The duration of treatment is noted and compared between groups
Time frame: Periprocedural
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jan 2028, 17 months later.
Of 44 non-industry interventional studies with no phase under Tooth Discoloration, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 17 months is above that.
Counting every sponsor, half of 52 studies reached it within 8 months; a quarter within 2 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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