Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children

NCT07730658 — Not applicable, Not yet recruiting, 56 participants, Marmara University

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Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children: A Randomized Clinical Trial

RegistryNCT07730658
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, basic science
Enrollment56 (Estimated)
SponsorMarmara University (Other)
ConditionsBlack Staining
InterventionsGuided Biofilm Therapy with erythritol, Conventional Polishing (Device)
Datesstart 2026-07-07 (estimated), primary completion 2028-01-01 (estimated), completion 2028-02-28 (estimated), first posted 2026-07-28, last updated 2026-07-28
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Black Staining All trials of Guided Biofilm Therapy with erythritol All trials of Conventional Polishing

-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 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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Group 1 (Erythritol Air-Polishing Using the EMS Air-Polishing Device)Active comparatorDevice: Guided Biofilm Therapy with erythritol
Group 2 (Conventional Polishing Using Prophylaxis Paste and a Polishing Brush)Active comparatorDevice: Conventional Polishing
  • Guided Biofilm Therapy with erythritol (Device): 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 Polishing (Device): 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.

+Outcome measures

Primary outcomes

  • Black Stain Score [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 [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 [Periprocedural]: The duration of treatment is noted and compared between groups

+Eligibility

Sex: All, ages: 4 Years to 13 Years, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (1)

FacilityCityCountryStatus
Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği FakültesiIstanbul, MALTEPETurkey (Türkiye)