Air-polishing With Erythritol During Orthodontic Tretament
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
Catherine Giannopoulou
60 participants
Sep 11, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria15
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05989750