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

Not Applicable

Recruiting

• Conditions: Black Stain; Black Plaque

• Registration Number: NCT06720168
• Lead Sponsor: Cardenal Herrera University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Study Start: 2024-12-05
• Study First Posted: 2024-12-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-05
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence of dental black stain	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 Outcome Measures

Name	Time	Method
Patient satisfaction	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).

Trial Locations

Locations (1)

Universidad CEU Cardenal Herrera; 🇪🇸 Alfara del Patriarca, Valencia, Spain