Status:
RECRUITING
Air-polishing With Erythritol During Orthodontic Tretament
Lead Sponsor:
Catherine Giannopoulou
Collaborating Sponsors:
University of Geneva, Switzerland
Conditions:
Inflammation Gum
White Spot Lesion
Eligibility:
All Genders
12-16 years
Phase:
NA
Brief 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 d...
Detailed 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. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05989750
Start Date
September 11 2023
End Date
September 1 2026
Last Update
December 5 2023
Active Locations (1)
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1
University of Geneva, University Clinics of Dental Medicine
Geneva, Switzerland, 1205