Using air-polishing with erythritol to prevent gum inflammation and white spots during orthodontic treatment
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
NA · University of Geneva, Switzerland · NCT05989750
This study is testing if using an air-polishing device with erythritol can help prevent gum inflammation and white spots in young people getting braces, compared to a regular cleaning method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years to 16 Years |
| Sex | All |
| Sponsor | University of Geneva, Switzerland (other) |
| Locations | 1 site (Geneva, Canton of Geneva) |
| Trial ID | NCT05989750 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of an air-polishing device using erythritol powder compared to the conventional ultrasonic scaler in preventing white spot lesions (WSLs) and gingivitis in young patients undergoing multi-bracketed fixed orthodontic treatment. The study involves 60 participants aged 12 to 16, who will be randomly assigned to receive either air-polishing or ultrasonic treatment during their orthodontic appointments over a period of two years. Clinical examinations and sample collections will occur at regular intervals to assess the prevalence of WSLs and gingivitis, as well as the antimicrobial efficacy against periodontal pathogens. The primary aim is to determine if air-polishing can serve as a viable monotherapy for these conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 12 to 16 who are about to begin fixed orthodontic treatment.
Not a fit: Patients with significant concomitant diseases, previous orthodontic treatment, or high plaque levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of white spot lesions and gingivitis in orthodontic patients, improving oral health outcomes.
How similar studies have performed: While the use of air-polishing in periodontal therapy has shown promise, this specific application during orthodontic treatment is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Geneva, Canton of Geneva
- University of Geneva, University Clinics of Dental Medicine — Geneva, Canton of Geneva, Switzerland (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inflammation Gum, White Spot Lesion