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

NCT ID: NCT06720168

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-05

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Black Stain Black Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dental prophylaxis with ultrasonic treatment

Dental Prophylaxis with ultrasonics

Group Type ACTIVE_COMPARATOR

Dental prophylaxis with ultrasonic treatment

Intervention Type DEVICE

Dental prophylaxis with ultrasonic treatment in patients with dental black stain

Dental prophylaxis with erythritol air polishing

Dental prophylaxis with erythritol air polishing application

Group Type EXPERIMENTAL

Erythritol air polisher

Intervention Type DEVICE

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

Interventions

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Erythritol air polisher

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

Intervention Type DEVICE

Dental prophylaxis with ultrasonic treatment

Dental prophylaxis with ultrasonic treatment in patients with dental black stain

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardenal Herrera University

OTHER

Sponsor Role lead

Responsible Party

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Chirag Sheth

Tenured Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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María del Mar Jovani-Sancho, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardenal Herrera University

Locations

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Universidad CEU Cardenal Herrera

Alfara del Patriarca, Valencia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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María del Mar Jovani-Sancho, DDS, PhD

Role: CONTACT

+34961369000 ext. 64302

Veronica Veses, BSc (Hon), PhD

Role: CONTACT

+34961369000 ext. 64524

Other Identifiers

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UCHCEU Jovani-Ribelles-Veses

Identifier Type: -

Identifier Source: org_study_id

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