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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06720168
Enrollment
40
Registered
2024-12-06
Start date
2024-12-05
Completion date
2026-07-31
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Black Plaque, Black Stain

Keywords

dental black stain, dental prophylaxis, erythritol air polisher

Brief summary

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.

Interventions

DEVICEDental prophylaxis with ultrasonic treatment

Dental prophylaxis with ultrasonic treatment in patients with dental black stain

DEVICEErythritol air polisher

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

Sponsors

Cardenal Herrera University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of dental black stain3, 6, 9 and 12 monthsFollowing dental prophylaxis (in each of the arms) the dentist will assess the recurrence of black stains at 3, 6, 9 and 12 months

Secondary

MeasureTime frameDescription
Patient satisfactionImmediately after the interventionPatients 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).

Countries

Spain

Contacts

Primary ContactMaría del Mar Jovani-Sancho, DDS, PhD
marjovani@uchceu.es+34961369000
Backup ContactVeronica Veses, BSc (Hon), PhD
veronica.veses@uchceu.es+34961369000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026