Inflammation GumAirPortNCT05989750
Air-polishing With Erythritol During Orthodontic Tretament
A study testing Ultrasonic scaler and Air-Flow Prophylaxis Master in people with Inflammation Gum and White Spot Lesion, run by Catherine Giannopoulou at 1 site in Switzerland.
Trial summary
Patients with multi-bracketed fixed orthodontic treatment are at increased risk of developing white spot lesions (WSL) and gingivitis. Various preventive strategies have been examined to prevent the development of WSLs. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation Gum, White Spot Lesion
- What is being tested?
- Ultrasonic scaler and Air-Flow Prophylaxis Master
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Sep 2023to 1 Sep 2028
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects about to undergo fixed orthodontic treatment will be invited to participate.
- Age between 12 and 16 years only participants
- Informed written consent obtained by the parents
Who cannot join
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
- Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
- Previous enrolment into the current investigation
- Enrolment of the PI, his/her family members, employees and other dependent persons
Show all 15Show fewer
- History of fixed orthodontic treatment
- Defects on enamel on labial surfaces of the teeth
- Untreated cavitated lesions
- Plaque levels >25%
- Periodontitis
- Multiple missing teeth
- Cleft lip and/or palate or other craniofacial anomalies or syndromes
- Patients taking any regular medication
- Patients with asthmatic problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Geneva, University Clinics of Dental Medicine
Geneva, Canton of Geneva, 1205
Catherine Giannopoulou, Dr med dent, 022 379 40 68, ekaterini.giannopoulou@unige.ch
Alkisti Zekeridou, Dr med dent, 022 379 40 30, alkisti.zekeridou@unige.ch
About this study
Official title: Air-polishing With Erythritol on Prevalence of White Spot Lesions and Gingivitis During Orthodontic Treatment With Fixed Appliances: a Randomized Clinical Trial of 2-years Duration
Patients with multi-bracketed fixed orthodontic treatment are at increased risk of developing white spot lesions (WSL) and gingivitis. Various preventive strategies have been examined to prevent the development of WSLs. During initial non-surgical periodontal therapy, the use of subgingival air-polishing with erythritol powder has shown promising results in reducing deep pockets and gingival inflammation. The efficacy of its use as monotherapy in preventing WSLs and gingival inflammation in patients during orthodontic treatment, has not yet been tested.
The primary objective of the present study is to compare the effectiveness of an air-polishing device used as monotherapy versus ultrasonic instrumentation (the current gold standard procedure) in preventing white spot lesions (WSL) and gingivitis among young patients undergoing multi-bracketed fixed orthodontic treatment.
Read the detailed description
This is a randomized clinical study for evaluating the performance of an air-polishing device in preventing WSLs and gingivitis among patients undergoing multi-bracketed fixed orthodontic treatment. The null hypothesis tested is that there is no difference between the air-polishing device and the conventional ultrasonic device in preventing WSLs and gingivitis during orthodontic treatment.
Clinical examination and clinical samples will be taken before, during and after orthodontic treatment. It is a single center study of 3 years duration involving samples of 60 patients attending the Division of Orthodontics for treatment. Half of the participants will be randomly assigned for treatment with the air-polishing device in every orthodontic appointment, meaning once per month, the other half will be treated with a standard ultrasonic scaler every six months. The study duration for each participant will be approximately 2 years. The investigators will then analyze the prevalence of WSLs using the Quantitative light-induced fluorescence (QLF) method. Gingivitis will be evaluated throughout the study by using standard clinical parameters; the antimicrobial efficacy against several known periodontal pathogens and the host-response (inflammatory markers in GCF) will be measured by the qPCR assay and the multiplex immunoassay, respectively. Clinical evaluation and collection of samples for microbial and host response analysis will be performed every 6 months. Incidence of bracket debonding we will be calculated and compared.
- Conditions
- Inflammation Gum, White Spot Lesion
- Being tested
- Ultrasonic scaler, Air-Flow Prophylaxis Master
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic scalerDevice
Ultrasonic scaling for subgingival cleaning every 6 months for 2 years according to the manufacturer's procedures.
Air-Flow Prophylaxis MasterDevice
AIR-FLOW PROPHYLAXIS MASTER with erythritol powder (AIR FLOW Powder Plus) will be used every month for 2 years for subgingival cleaning according to the manufacturer's procedures.
| Study group | Role | What they receive |
|---|---|---|
| Control procedure | Active comparator | Ultrasonic scaling and polishing will be performed every 6 months for subgingival cleaning Receives: Device: Ultrasonic scaler |
| Test procedure | Experimental | AIR-FLOW PROPHYLAXIS MASTER with erythritol powder (AIR FLOW Powder Plus) will be used every month for 2 years for subgingival cleaning Receives: Device: Air-Flow Prophylaxis Master |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of white spot lesions (WSL) during orthodontic movement with fixed appliances.
Number of participants with white spot lesions appearence during the 2-years period of orthodontic treatment
Measured: 2 years
Appearance on inflammatory lesions during orthodontic treatmnet
Number of participants showing signs of inflammation based on clinical parameters during the 2-year period of orthodontic treatment.
Measured: 2 years
Changes from baseline in clinical parameters
plaque accumulation gingival inflammation pocket probing depth bleeding on probing gingival recessions
Measured: 2 years
Secondary outcomes (5)
Patient acceptance
Visual Analogue Scale (VAS) with 0: very satisfied and 10: unsatisfied
Measured: 2 years
Tooth sensitivity
Visual Analogue Scale (VAS) with 0: no sensitivity and 10: worst senstitivity
Measured: 2 years
Total bacterial counts and counts of 6 periodontal pathogens in subgingival samples from treated pockets
Changes from baseline of microorganisms will be identified and enumerated by laboratory Real-time Polymerase Chain Reaction
Measured: 2 years
Inflammatory markers in GCF from baseline
Changes of the Inflammatory markers in the gingival crevicular fluid (GCF) throughout the study will be analyzed by the Bioplex 200 Suspension array system. The concentration of these markers will be expreseed as pg/ml
Measured: 2 years
Toral tretament time
Treatment time will be recorded at each visit
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start11 Sep 2023
- Primary completion11 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammation GumStudies 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
- Model description
- Randomized, examiner-masked clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catherine Giannopoulou
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Responsible party
- Sponsor-investigator, Catherine Giannopoulou, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989750
- Sponsor's protocol ID
- BASEC 2023-D0032
- Acronym
- AirPort
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air-polishing With Erythritol on Prevalence of White Spot Lesions and Gingivitis During Orthodontic Treatment With Fixed Appliances: a Randomized Clinical Trial of 2-years Duration
- ClinicalTrials.gov ID
- NCT05989750
- Acronym / sponsor ID
- AirPort / BASEC 2023-D0032
- Conditions
- Inflammation Gum, White Spot Lesion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Catherine GiannopoulouUniversity, hospital or other
- Collaborators
- University of Geneva, Switzerland
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 11 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 14 Aug 2023 (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.
Patients with multi-bracketed fixed orthodontic treatment are at increased risk of developing white spot lesions (WSL) and gingivitis. Various preventive strategies have been examined to prevent the development of WSLs. During initial non-surgical periodontal therapy, the use of subgingival air-polishing with erythritol powder has shown promising results in reducing deep pockets and gingival inflammation. The efficacy of its use as monotherapy in preventing WSLs and gingival inflammation in patients during orthodontic treatment, has not yet been tested.
The primary objective of the present study is to compare the effectiveness of an air-polishing device used as monotherapy versus ultrasonic instrumentation (the current gold standard procedure) in preventing white spot lesions (WSL) and gingivitis among young patients undergoing multi-bracketed fixed orthodontic treatment.
Detailed description
This is a randomized clinical study for evaluating the performance of an air-polishing device in preventing WSLs and gingivitis among patients undergoing multi-bracketed fixed orthodontic treatment. The null hypothesis tested is that there is no difference between the air-polishing device and the conventional ultrasonic device in preventing WSLs and gingivitis during orthodontic treatment.
Clinical examination and clinical samples will be taken before, during and after orthodontic treatment. It is a single center study of 3 years duration involving samples of 60 patients attending the Division of Orthodontics for treatment. Half of the participants will be randomly assigned for treatment with the air-polishing device in every orthodontic appointment, meaning once per month, the other half will be treated with a standard ultrasonic scaler every six months. The study duration for each participant will be approximately 2 years. The investigators will then analyze the prevalence of WSLs using the Quantitative light-induced fluorescence (QLF) method. Gingivitis will be evaluated throughout the study by using standard clinical parameters; the antimicrobial efficacy against several known periodontal pathogens and the host-response (inflammatory markers in GCF) will be measured by the qPCR assay and the multiplex immunoassay, respectively. Clinical evaluation and collection of samples for microbial and host response analysis will be performed every 6 months. Incidence of bracket debonding we will be calculated and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized, examiner-masked clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control procedure | Active comparator | Device: Ultrasonic scalerUltrasonic scaling and polishing will be performed every 6 months for subgingival cleaning |
| Test procedure | Experimental | Device: Air-Flow Prophylaxis MasterAIR-FLOW PROPHYLAXIS MASTER with erythritol powder (AIR FLOW Powder Plus) will be used every month for 2 years for subgingival cleaning |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects about to undergo fixed orthodontic treatment will be invited to participate.
- Age between 12 and 16 years only participants
- Informed written consent obtained by the parents
Key exclusion criteria (15 listed)
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
- Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
- Previous enrolment into the current investigation
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 |
|---|---|---|
| Ultrasonic scalerUltrasonic scaling for subgingival cleaning every 6 months for 2 years according to the manufacturer's procedures. | Device | Control procedure |
| Air-Flow Prophylaxis MasterAIR-FLOW PROPHYLAXIS MASTER with erythritol powder (AIR FLOW Powder Plus) will be used every month for 2 years for subgingival cleaning according to the manufacturer's procedures. | Device | Test procedure |
Primary outcome
Appearance of white spot lesions (WSL) during orthodontic movement with fixed appliances.
Time frame: 2 years
Number of participants with white spot lesions appearence during the 2-years period of orthodontic treatment
Appearance on inflammatory lesions during orthodontic treatmnet
Time frame: 2 years
Number of participants showing signs of inflammation based on clinical parameters during the 2-year period of orthodontic treatment.
Changes from baseline in clinical parameters
Time frame: 2 years
plaque accumulation gingival inflammation pocket probing depth bleeding on probing gingival recessions
5 secondary outcomes
Patient acceptance
Time frame: 2 years
Tooth sensitivity
Time frame: 2 years
Total bacterial counts and counts of 6 periodontal pathogens in subgingival samples from treated pockets
Time frame: 2 years
Inflammatory markers in GCF from baseline
Time frame: 2 years
Toral tretament time
Time frame: 2 years
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 5 May 2026.
- Individual participant dataSharing planned: No
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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.
University of Geneva, University Clinics of Dental Medicine
Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic scaler and Air-Flow Prophylaxis Master in people with Inflammation Gum and White Spot Lesion, run by Catherine Giannopoulou at 1 site in Switzerland.
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 3 inclusion and 15 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 5 May 2026. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearance of white spot lesions (WSL) during orthodontic movement with fixed appliances. (time frame: 2 years). The study lists 3 primary outcomes in all. 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 5 May 2026.