Air-polishing With Erythritol During Orthodontic Tretament (AirPort)

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.

Study Overview

• Status: Recruiting
• Conditions: White Spot Lesion; Inflammation Gum
• Intervention / Treatment: Device: Ultrasonic scaler; Device: Air-Flow Prophylaxis Master

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Geneva
    • Geneva, Canton of Geneva, Switzerland, 1205
      • Recruiting
      • University of Geneva, University Clinics of Dental Medicine
      • Contact: Catherine Giannopoulou, Dr med dent; Phone Number: 022 379 40 68; Email: ekaterini.giannopoulou@unige.ch
      • Contact: Alkisti Zekeridou, Dr med dent; Phone Number: 022 379 40 30; Email: alkisti.zekeridou@unige.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control procedure; Ultrasonic scaling and polishing will be performed every 6 months for subgingival cleaning	Device: Ultrasonic scaler; Ultrasonic scaling for subgingival cleaning every 6 months for 2 years according to the manufacturer's procedures.
Experimental: Test procedure; AIR-FLOW PROPHYLAXIS MASTER with erythritol powder (AIR FLOW Powder Plus) will be used every month for 2 years for subgingival cleaning	Device: Air-Flow Prophylaxis Master; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in clinical parameters	plaque accumulation gingival inflammation pocket probing depth bleeding on probing gingival recessions	2 years
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	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient acceptance	Visual Analogue Scale (VAS) with 0: very satisfied and 10: unsatisfied	2 years
Tooth sensitivity	Visual Analogue Scale (VAS) with 0: no sensitivity and 10: worst senstitivity	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	2 years
Toral tretament time	Treatment time will be recorded at each visit	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	2 years

Collaborators and Investigators

• Sponsor: Catherine Giannopoulou
• Collaborators: University of Geneva, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): September 11, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis
• Other Study ID Numbers: BASEC 2023-D0032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes