CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 142 enrolled
Drug / intervention
Two-step ultrasonic protocol +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07304310
NCT07304310N/ACompleted

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

IRCCS San Raffaele·observational·Posted Dec 26, 2025·Updated Dec 26, 2025

In Brief

An observational study evaluating Two-step ultrasonic protocol and One-step clean-up protocol for Orthodontic Appliance and 2 related conditions. Completed, enrolled 142 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2026
First PostedDec 26, 2025
Enrollment StartApr 8, 2025
Primary CompletionSep 1, 2025
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6 months ago

Interventions

Two-step ultrasonic protocoldevice

Diamond- and PEEK-coated inserts

One-step clean-up protocoldevice

One-step tungsten carbide/abrasive polisher