An observational study in Orthodontic Appliance, Debonding and Case-control Study, sponsored by IRCCS San Raffaele. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by IRCCS San Raffaele · Observational
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.
IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consisted of 142 consecutive patients requiring adhesive removal following orthodontic debonding. Participants were recruited at the Oral Hygiene and Prevention Center of the Department of Dentistry, San Raffaele Hospital, and at the Smart Dental Clinics (San Donato Group), Milan, Italy, between April 2025 and September 2025.
Exclusion Criteria:
Patients underwent orthodontic clean-up with a two-step ultrasonic system (Combi Touch, Mectron) equipped with 30-µm diamond-coated and PEEK-coated inserts
Device: Two-step ultrasonic protocol
Patients underwent orthodontic clean-up with a one-step tungsten carbide/abrasive polisher (One Gloss®, Shofu)
Device: One-step clean-up protocol
Diamond- and PEEK-coated inserts
One-step tungsten carbide/abrasive polisher
Plaque Control Record (PCR)
The PCR is scored as the percentage of tooth surfaces with visible plaque (0-100%). Higher scores indicate worse oral hygiene.
Time frame: Baseline, after 30 days
Bleeding on Probing (BoP)
BoP is expressed as the percentage of bleeding sites (0-100%). Higher scores indicate worse gingival health.
Time frame: Baseline, after 30 days
Adhesive Remnant Index (ARI)
The ARI is scored 0-3, where 0 = no adhesive left on tooth surface and 3 = all adhesive remaining. Higher scores indicate more adhesive remaining on the enamel.
Time frame: Baseline, after 30 days
International Caries Detection and Assessment System (ICDAS-II)
The ICDAS-II is scored from 0 to 6, where 0 = sound tooth surface and 6 = extensive cavitated lesion. Higher scores indicate worse caries status.
Time frame: Baseline, after 30 days
Schiff Air Index
The Schiff Air Index scored from 0 to 3, where 0 = no response to air stimulus and 3 = strong painful response. Higher scores indicate greater dentinal hypersensitivity.
Time frame: Baseline, after 30 days
Orthodontic treatment modality
Orthodontic treatment modality was recorded as a categorical variable at baseline (T0), distinguishing between the use of clear aligners and fixed appliances. This variable does not follow a numerical scale; instead, it consists of two categories. No minimum or maximum values apply, and higher values do not correspond to better or worse outcomes.
Time frame: Baseline
Plan to share: Undecided
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele