NCT07304310

Comparison of Two Orthodontic Clean-Up Protocols

Clinical Evaluation of Two Minimally Invasive Protocols for Orthodontic Clean-Up: A Case-Control Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 142 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Orthodontic Appliance
• Debonding
• Case-control Study

Interventions

Type	Name	Description
DEVICE	Two-step ultrasonic protocol	Diamond- and PEEK-coated inserts
DEVICE	One-step clean-up protocol	One-step tungsten carbide/abrasive polisher

Timeline

• Start date: 2025-04-08
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: Italy