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Comparison of Two Orthodontic Clean-Up Protocols

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07304310
Enrollment
142
Registered
2025-12-26
Start date
2025-04-08
Completion date
2025-09-01
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Case-control Study, Debonding, Orthodontic Appliance

Keywords

orthodontic clean-up, orthodontic debonding, enamel preservation, minimally invasive dentistry, case-control study

Brief 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.

Interventions

DEVICETwo-step ultrasonic protocol

Diamond- and PEEK-coated inserts

DEVICEOne-step clean-up protocol

One-step tungsten carbide/abrasive polisher

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Plaque Control Record (PCR)Baseline, after 30 daysThe PCR is scored as the percentage of tooth surfaces with visible plaque (0-100%). Higher scores indicate worse oral hygiene.
Bleeding on Probing (BoP)Baseline, after 30 daysBoP is expressed as the percentage of bleeding sites (0-100%). Higher scores indicate worse gingival health.
Adhesive Remnant Index (ARI)Baseline, after 30 daysThe 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.
International Caries Detection and Assessment System (ICDAS-II)Baseline, after 30 daysThe ICDAS-II is scored from 0 to 6, where 0 = sound tooth surface and 6 = extensive cavitated lesion. Higher scores indicate worse caries status.
Schiff Air IndexBaseline, after 30 daysThe 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.

Secondary

MeasureTime frameDescription
Orthodontic treatment modalityBaselineOrthodontic 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026