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NCT Number: NCT07730658

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

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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Key information

Conditions

Black Staining Stomatognathic Diseases Tooth Discoloration Tooth Diseases

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi

Istanbul, MALTEPE, 34854, Turkey (Türkiye)

Location contact

Betul Sen Yavuz

CONTACT

[email protected]

+90 539 988 76 46

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

    • 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.

  2. 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).

  3. Time Session

    Time frame: Periprocedural

    The duration of treatment is noted and compared between groups

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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