Black StainNCT06720168
Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin
A study testing Erythritol air polisher and Dental prophylaxis with ultrasonic treatment in people with Black Stain and Black Plaque, run by Cardenal Herrera University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Black Stain, Black Plaque
- What is being tested?
- Erythritol air polisher and Dental prophylaxis with ultrasonic treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2024to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with 2 or more teeth with black stain
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad CEU Cardenal Herrera
Alfara del Patriarca, Valencia, 46115
About this study
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.
- Conditions
- Black Stain, Black Plaque
- Being tested
- Erythritol air polisher, Dental prophylaxis with ultrasonic treatment
- Keywords
- dental black stain, dental prophylaxis, erythritol air polisher
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythritol air polisherDevice
Dental prophylaxis with erythritol air polisher in patients with dental black stain
Dental prophylaxis with ultrasonic treatmentDevice
Dental prophylaxis with ultrasonic treatment in patients with dental black stain
| Study group | Role | What they receive |
|---|---|---|
| Dental prophylaxis with ultrasonic treatment | Active comparator | Dental Prophylaxis with ultrasonics Receives: Device: Dental prophylaxis with ultrasonic treatment |
| Dental prophylaxis with erythritol air polishing | Experimental | Dental prophylaxis with erythritol air polishing application Receives: Device: Erythritol air polisher |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3, 6, 9 and 12 months
Secondary 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).
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start5 Dec 2024
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Black StainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chirag Sheth, Cardenal Herrera University
- Investigators
- María del Mar Jovani-Sancho, DDS, PhD, Principal investigator, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720168
- Sponsor's protocol ID
- UCHCEU Jovani-Ribelles-Veses
- Status last verified
- Feb 2025
- First submitted
- 3 Dec 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin
- ClinicalTrials.gov ID
- NCT06720168
- Acronym / sponsor ID
- UCHCEU Jovani-Ribelles-Veses
- Conditions
- Black Stain, Black Plaque
- Keywords
- dental black stain, dental prophylaxis, erythritol air polisher
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental prophylaxis with ultrasonic treatment | Active comparator | Device: Dental prophylaxis with ultrasonic treatmentDental Prophylaxis with ultrasonics |
| Dental prophylaxis with erythritol air polishing | Experimental | Device: Erythritol air polisherDental prophylaxis with erythritol air polishing application |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with 2 or more teeth with black stain
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythritol air polisherDental prophylaxis with erythritol air polisher in patients with dental black stain | Device | Dental prophylaxis with erythritol air polishing |
| Dental prophylaxis with ultrasonic treatmentDental prophylaxis with ultrasonic treatment in patients with dental black stain | Device | Dental prophylaxis with ultrasonic treatment |
Primary outcome
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
1 secondary outcome
Patient satisfaction
Time frame: Immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Black Stain
Not yet recruiting
Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children
Black Staining
Recruiting
A Crossover Clinical Study to Evaluate the Effect of Chitosan Mouthwash on Recurrence of Black Stains in Pediatric Patients
Black Stains
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María del Mar Jovani-Sancho, DDS, PhD principal investigator
Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erythritol air polisher and Dental prophylaxis with ultrasonic treatment in people with Black Stain and Black Plaque, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María del Mar Jovani-Sancho, DDS, PhD (+34961369000 ext. 64302, marjovani@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of dental black stain (time frame: 3, 6, 9 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.