Menu
Not yet recruiting NCT07730658

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

No phase Interventional Black Staining

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Guided Biofilm Therapy with erythritol, Conventional Polishing.
Who it may be relevant to
Registry conditions: Black Staining. Basic parameters: 4 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Device Guided Biofilm Therapy with erythritol
    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.
  • Device Conventional Polishing
    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 outcome measures

  • Black Stain Score [Time frame: Baseline, immediately after polishing, 1 month, 2 months, 3 months, and 6 months]
  • Participant Feedback [Time frame: Periprocedural]
  • Time Session [Time frame: Periprocedural]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Turkey (Türkiye) · 1 center
  • Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakül — Istanbul

Identifiers

NCT: NCT07730658 · GBTvschromogenic

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗