Air-polishing With Erythritol During Orthodontic Tretament

White Spot Lesion Clinical Trial

— AirPort  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989750
• Other study ID #: BASEC 2023-D0032
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: September 2026

Study information

• Verified date: November 2023
• Source: University of Geneva, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2026
• Est. primary completion date: September 11, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Inflammation
• Inflammation Gum
• White Spot Lesion

Intervention

Device:
• Ultrasonic scaler
Ultrasonic scaling for subgingival cleaning every 6 months for 2 years according to the manufacturer's procedures.
• 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.

Locations

Country	Name	City	State
Switzerland	University of Geneva, University Clinics of Dental Medicine	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Catherine Giannopoulou	University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Changes from baseline in clinical parameters	plaque accumulation gingival inflammation pocket probing depth bleeding on probing gingival recessions	2 years
Secondary	Patient acceptance	Visual Analogue Scale (VAS) with 0: very satisfied and 10: unsatisfied	2 years
Secondary	Tooth sensitivity	Visual Analogue Scale (VAS) with 0: no sensitivity and 10: worst senstitivity	2 years
Secondary	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
Secondary	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
Secondary	Toral tretament time	Treatment time will be recorded at each visit	2 years