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Completed

NCT Number: NCT07304310

Comparison of Two Orthodontic Clean-Up Protocols

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Dental Clinic, IRCCS San Raffaele Hospital

Milan, Italy, 20132

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Two-step ultrasonic protocol

Device

Diamond- and PEEK-coated inserts

One-step clean-up protocol

Device

One-step tungsten carbide/abrasive polisher

Primary outcomes

  1. Plaque Control Record (PCR)

    Time frame: Baseline, after 30 days

    The PCR is scored as the percentage of tooth surfaces with visible plaque (0-100%). Higher scores indicate worse oral hygiene.

  2. Bleeding on Probing (BoP)

    Time frame: Baseline, after 30 days

    BoP is expressed as the percentage of bleeding sites (0-100%). Higher scores indicate worse gingival health.

  3. Adhesive Remnant Index (ARI)

    Time frame: Baseline, after 30 days

    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.

  4. International Caries Detection and Assessment System (ICDAS-II)

    Time frame: Baseline, after 30 days

    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.

  5. Schiff Air Index

    Time frame: Baseline, after 30 days

    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.

Secondary outcomes

  1. Orthodontic treatment modality

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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