Air-polishing With Erythritol During Orthodontic Tretament
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-16
SponsorCatherine Giannopoulou
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasonic scaler
DeviceUltrasonic scaling for subgingival cleaning every 6 months for 2 years according to the manufacturer's procedures.
Air-Flow Prophylaxis Master
DeviceAIR-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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control procedureActive comparator 1 intervention
Group B: Test procedureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 years2
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 years3
Changes from baseline in clinical parameters
plaque accumulation gingival inflammation pocket probing depth bleeding on probing gingival recessions
Time frame
2 yearsSecondary outcomes
1
Patient acceptance
Visual Analogue Scale (VAS) with 0: very satisfied and 10: unsatisfied
Time frame
2 years2
Tooth sensitivity
Visual Analogue Scale (VAS) with 0: no sensitivity and 10: worst senstitivity
Time frame
2 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Catherine Giannopoulou
Lead sponsor
University of Geneva, Switzerland
Sponsor institution
University of Geneva, Switzerland
Collaborator
Source ClinicalTrials.gov