Comparison of Two Orthodontic Clean-Up Protocols

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

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 Overview

• Status: Completed
• Conditions: Orthodontic Appliance; Case-control Study; Debonding
• Intervention / Treatment: Device: Two-step ultrasonic protocol; Device: One-step clean-up protocol

• Study Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• Italy
  • Italy
    • Milan, Italy, Italy, 20132
      • Dental Clinic, IRCCS San Raffaele Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group; 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; Diamond- and PEEK-coated inserts
Control group; Patients underwent orthodontic clean-up with a one-step tungsten carbide/abrasive polisher (One Gloss®, Shofu)	Device: One-step clean-up protocol; One-step tungsten carbide/abrasive polisher

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Baseline, after 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Publications and helpful links

General Publications

• Pont HB, Ozcan M, Bagis B, Ren Y. Loss of surface enamel after bracket debonding: an in-vivo and ex-vivo evaluation. Am J Orthod Dentofacial Orthop. 2010 Oct;138(4):387.e1-387.e9. doi: 10.1016/j.ajodo.2010.01.028.
• D'Amario M, Bernardi S, Di Lauro D, Marzo G, Macchiarelli G, Capogreco M. Debonding and Clean-Up in Orthodontics: Evaluation of Different Techniques and Micro-Morphological Aspects of the Enamel Surface. Dent J (Basel). 2020 Jun 17;8(2):58. doi: 10.3390/dj8020058.
• Thawaba AA, Albelasy NF, Elsherbini AM, Hafez AM. Evaluation of enamel roughness after orthodontic debonding and clean-up procedures using zirconia, tungsten carbide, and white stone burs: an in vitro study. BMC Oral Health. 2023 Jul 13;23(1):478. doi: 10.1186/s12903-023-03194-6.
• Campbell PM. Enamel surfaces after orthodontic bracket debonding. Angle Orthod. 1995;65(2):103-10. doi: 10.1043/0003-3219(1995)0652.0.CO;2.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2025
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: case-control study; minimally invasive dentistry; orthodontic clean-up; orthodontic debonding; enamel preservation
• Other Study ID Numbers: OCUs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No