Air-polishing With Erythritol During Orthodontic Tretament

NCT05989750 | Recruiting DMC FDA Device

• 1 other identifier: BASEC 2023-D0032
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Inflammation Gum; White Spot Lesion

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Changes from baseline in clinical parameters

  plaque accumulation gingival inflammation pocket probing depth bleeding on probing gingival recessions

  2 years

Secondary Outcomes (5)

• Patient acceptance

  2 years

• Tooth sensitivity

  2 years

• Total bacterial counts and counts of 6 periodontal pathogens in subgingival samples from treated pockets

  2 years

• Inflammatory markers in GCF from baseline

  2 years

• Toral tretament time

  2 years

Study Arms (2)

Control procedure

ACTIVE COMPARATOR

Ultrasonic scaling and polishing will be performed every 6 months for subgingival cleaning

Device: Ultrasonic scaler

Test procedure

EXPERIMENTAL

AIR-FLOW PROPHYLAXIS MASTER with erythritol powder (AIR FLOW Powder Plus) will be used every month for 2 years for subgingival cleaning

Device: Air-Flow Prophylaxis Master

Interventions

Ultrasonic scaler DEVICE

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

Control procedure

Air-Flow Prophylaxis Master DEVICE

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.

Test procedure

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Geneva, Switzerland: collaborator
• Catherine Giannopoulou: lead

Study Sites (1)

University of Geneva, University Clinics of Dental Medicine

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The examiner, the biostatistician and people working in the laboratory for the analyses, will be blinded for allocation group. Only the operator and the participant will be aware of the type of treatment based on the computer-generated allocation table that will be kept at the Trial Master File (TMF) of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, examiner-masked clinical trial

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 14, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): September 11, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)