Comparison of Two Orthodontic Clean-Up Protocols

San Donato Group (GSD)

Status: Completed

Conditions: Orthodontic Appliance; Debonding; Case-control Study

Treatments: Device: Two-step ultrasonic protocol; Device: One-step clean-up protocol

Study type: Observational

Funder types: Other

Identifiers

NCT07304310

OCUs

Details and patient eligibility

About

Orthodontic clean-up following debonding remains a technically demanding procedure, with documented risks of enamel roughening, microdefects, discoloration, and increased plaque retention. Minimally invasive technologies have recently been introduced to improve adhesive removal while limiting damage to the outer enamel layer, but comparative clinical evidence remains limited. This aim of this case-control study was to compare the effectiveness and the safety of two different minimally invasive clean-up systems: two-step ultrasonic inserts (Combi Touch, Mectron) and a one-step polishing bur (One Gloss®, Shofu).

A total of 142 patients presenting residual orthodontic adhesive after debonding were included. They were randomly allocated to: (1) Case group (n = 71): two-step ultrasonic system (Combi Touch, Mectron) equipped with 30-µm diamond-coated and PEEK-coated inserts; (2) Control group (n= 71): one-step tungsten carbide/abrasive polisher (One Gloss®, Shofu). For each patient the following clinical indices were recorded at baseline (T0) and 30-day follow-up (T1): Plaque Control Record (PCR), Bleeding on Probing (BoP), Adhesive Remnant Index (ARI), International Caries Detection and Assessment System (ICDAS-II), and dentinal sensitivity (Schiff Air Index). Orthodontic treatment modality (clear aligners vs fixed appliances) was documented as a covariate and tested for potential interactions with clinical outcomes.

Enrollment: 142 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergone either fixed vestibular orthodontic treatment or clear aligner therapy
• Debonding procedure must not have occurred more than 24 months prior to evaluation
• ICDAS-II index ≤ 2

Exclusion criteria

• Patients treated with removable orthodontic appliances
• Patients whose debonding exceeded 24 months
• ICDAS-II score > 2

Trial design

142 participants in 2 patient groups

Case group

Description:

Patients underwent orthodontic clean-up with a two-step ultrasonic system (Combi Touch, Mectron) equipped with 30-µm diamond-coated and PEEK-coated inserts

Treatment:

Device: Two-step ultrasonic protocol

Control group

Description:

Patients underwent orthodontic clean-up with a one-step tungsten carbide/abrasive polisher (One Gloss®, Shofu)

Treatment:

Device: One-step clean-up protocol