Actively Recruiting
Air-polishing With Erythritol on White Spot Lesions and Gingivitis During Fixed Orthodontic Treatment: A 2-Year Randomized Clinical Trial
Led by Catherine Giannopoulou · Updated on 2026-05-05
60
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
Sponsors
C
Catherine Giannopoulou
Lead Sponsor
U
University of Geneva, Switzerland
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness of an air-polishing device using erythritol powder with the standard ultrasonic scaler in preventing white spot lesions (WSLs) and gingivitis in young patients undergoing multi-bracketed fixed orthodontic treatment. It addresses the increased risk of WSLs and gum inflammation during such orthodontic care and tests whether the air-polishing device as monotherapy can reduce these issues. Participants will be randomly assigned to one of two groups: one receiving subgingival cleaning with an air-polishing device every month for 2 years, and the other undergoing ultrasonic scaling every six months for the same period. Both treatments follow manufacturer procedures, with the air-polishing device using erythritol powder. The study is a single-center, randomized clinical trial lasting approximately 3 years with a 2-year participation duration per patient. Participants will undergo clinical exams and sample collections before, during, and after orthodontic treatment. Assessments include the prevalence of WSLs measured by Quantitative Light-induced Fluorescence (QLF), gingivitis evaluation with clinical parameters, bacterial counts from subgingival samples, and inflammatory markers in gingival crevicular fluid. These evaluations and sample collections occur every 6 months. The study also tracks bracket debonding and total treatment time, supporting comprehensive monitoring during the trial.
CONDITIONS
Brief Title
Air-polishing With Erythritol During Orthodontic Tretament
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects about to undergo fixed orthodontic treatment
- Age between 12 and 16 years
- Informed written consent obtained by the parents
You will not qualify if you...
- Clinically significant diseases such as renal failure, hepatic dysfunction, or cardiovascular disease
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow study procedures due to language, psychological, or cognitive issues
- Participation in another investigational study within 30 days before or during this study
- Previous enrollment in this study
- Enrollment of the principal investigator, their family, employees, or dependents
- History of fixed orthodontic treatment
- Enamel defects on the front surfaces of teeth
- Untreated cavitated dental lesions
- Plaque levels over 25%
- Periodontitis
- Multiple missing teeth
- Cleft lip, palate, or other craniofacial anomalies or syndromes
- Use of any regular medication
- Asthmatic problems
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 years
Participants receive subgingival cleaning during orthodontic treatment. Those in the test group receive air-polishing with erythritol every month, while the control group receives ultrasonic scaling every six months.
Monthly visits for air-polishing group; visits every 6 months for ultrasonic scaler group
Duration - Every 6 months during the 2-year treatment period
Clinical evaluations and collection of samples for microbial and inflammatory marker analysis occur during orthodontic treatment to assess white spot lesions and gingivitis.
Visits every 6 months for clinical evaluation and sample collection
Trial Site Locations
Total: 1 location
1
University of Geneva, University Clinics of Dental Medicine
Geneva, Canton of Geneva, Switzerland, 1205
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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