Air-polishing With Erythritol During Orthodontic Tretament

Launched by CATHERINE GIANNOPOULOU · Aug 4, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of a special air-polishing device that uses erythritol powder to help prevent white spot lesions (WSL) and gum inflammation in young patients who are receiving orthodontic treatment with braces. White spot lesions are areas of demineralization on teeth that can occur during orthodontic treatment, and gum inflammation is a common issue. The study aims to see how well this air-polishing method works compared to the traditional cleaning method called ultrasonic instrumentation, which is currently the standard practice.

To be eligible for this study, participants should be between 12 and 16 years old and about to start fixed orthodontic treatment. Parents will need to provide written consent for their child to participate. The trial is currently recruiting participants, and it’s important to note that those with certain health conditions, previous orthodontic treatment, or other specific dental issues will not be able to join. If selected, participants can expect to receive either the new air-polishing treatment or the standard cleaning procedure during their orthodontic care, helping researchers learn more about how to maintain dental health during braces.

Gender

ALL

Eligibility criteria

• 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