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Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 19, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Start date changed from estimate of Dec 2024 to Dec 5, 2024v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Interventions: Dental prophylaxis with ultrasonics (Device), Erythritol air polisher (Device) to Dental prophylaxis with ultrasonic treatment (Device), Erythritol air polisher (Device)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Black stains on the teeth, caused by the accumulation of chromogenic microorganisms that produce iron compounds, are more common in the pediatric population and have a negative impact on dental aesthetics and patients' self-esteem. The etiology of these stains remains unclear and is not related to oral hygiene. Currently, there is no definitive treatment that prevents the reappearance of these stains, and they can only be removed by mechanical removal, which can cause injuries to the tooth structure. This study aims to evaluate the effectiveness of erythritol powder air polishers, which have antimicrobial properties, compared to conventional prophylaxis in preventing the recurrence of stains. A randomized clinical trial will be carried out with a follow-up of 12 months, during which patient satisfaction and duration of treatment will be assessed. The results of this study could provide valuable information to improve treatment and management strategies for dental stains in the affected population, thus contributing to the emotional well-being of patients and reducing damage to their tooth enamel.
Trial Details
NCT Number NCT06720168
Lead Sponsor Cardenal Herrera University
Conditions
(from sponsor)		 Black Stain, Black Plaque
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov