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NCT Number: NCT06720168

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad CEU Cardenal Herrera

Alfara del Patriarca, Valencia, 46115, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with 2 or more teeth with black stain

Exclusion criteria

  • Sistemic diseases
  • Patients with physical and/or cognitive impairment which prevents participation in a dental prophylaxis.
  • Use of oral antibiotics fifteen days before the intervention
  • Allergy to erythritol

Treatment and study plan

Erythritol air polisher

Device

Dental prophylaxis with erythritol air polisher in patients with dental black stain

Dental prophylaxis with ultrasonic treatment

Device

Dental prophylaxis with ultrasonic treatment in patients with dental black stain

Primary outcomes

  1. Recurrence of dental black stain

    Time frame: 3, 6, 9 and 12 months

    Following dental prophylaxis (in each of the arms) the dentist will assess the recurrence of black stains at 3, 6, 9 and 12 months

Secondary outcomes

  1. Patient satisfaction

    Time frame: Immediately after the intervention

    Patients will received, at the end of the procedure a questionnaire to evaluate their satisfaction with the care provided, evaluating from 0 to 5 the level of disconfort experienced during the treatment (0 no disconfort, 5 maximum disconfort).

Study contacts

Contact information is provided by the study sponsor or research team.

María del Mar Jovani-Sancho, DDS, PhD

CONTACT

[email protected]

+34961369000 ext. 64302

Veronica Veses, BSc (Hon), PhD

CONTACT

[email protected]

+34961369000 ext. 64524

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2024
Registry last updated
Feb 19, 2025

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.