Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCardenal Herrera University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with 2 or more teeth with black stain
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Erythritol air polisher
DeviceDental prophylaxis with erythritol air polisher in patients with dental black stain
Dental prophylaxis with ultrasonic treatment
DeviceDental prophylaxis with ultrasonic treatment in patients with dental black stain
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Dental prophylaxis with ultrasonic treatmentActive comparator 1 intervention
Group B: Dental prophylaxis with erythritol air polishingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recurrence of dental black stain
Following dental prophylaxis (in each of the arms) the dentist will assess the recurrence of black stains at 3, 6, 9 and 12 months
Time frame
3, 6, 9 and 12 monthsSecondary outcomes
1
Patient satisfaction
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).
Time frame
Immediately after the interventionSponsors and contacts
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Source ClinicalTrials.gov