An interventional study of Ultrasonic scaler and Air-Flow Prophylaxis Master in Inflammation Gum and White Spot Lesion, sponsored by Catherine Giannopoulou. Recruiting at 1 site in Switzerland. Open to participants aged 12 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Catherine Giannopoulou · Not applicable, Interventional, and Treatment
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.
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.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →This is the only study on the registry with Catherine Giannopoulou as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A drug or device being studied in a clinical trial.
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Clinically significant
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ultrasonic scaling and polishing will be performed every 6 months for subgingival cleaning
Device: Ultrasonic scaler
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
Ultrasonic scaling for subgingival cleaning every 6 months for 2 years according to the manufacturer's procedures.
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.
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
Time frame: 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.
Time frame: 2 years
Changes from baseline in clinical parameters
plaque accumulation gingival inflammation pocket probing depth bleeding on probing gingival recessions
Time frame: 2 years
Patient acceptance
Visual Analogue Scale (VAS) with 0: very satisfied and 10: unsatisfied
Time frame: 2 years
Tooth sensitivity
Visual Analogue Scale (VAS) with 0: no sensitivity and 10: worst senstitivity
Time frame: 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
Time frame: 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
Time frame: 2 years
Toral tretament time
Treatment time will be recorded at each visit
Time frame: 2 years
Plan to share: No
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