Comparison of Two Orthodontic Clean-Up Protocols

NCT07304310 | Completed

• 1 other identifier: OCUs
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Appliance; Debonding; Case-control Study

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Orthodontic treatment modality

  Baseline

Study Arms (2)

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

Control group

Patients underwent orthodontic clean-up with a one-step tungsten carbide/abrasive polisher (One Gloss®, Shofu)

Device: One-step clean-up protocol

Interventions

Two-step ultrasonic protocol DEVICE

Diamond- and PEEK-coated inserts

Case group

One-step clean-up protocol DEVICE

One-step tungsten carbide/abrasive polisher

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients treated with removable orthodontic appliances
• Patients whose debonding exceeded 24 months
• ICDAS-II score \> 2

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Dental Clinic, IRCCS San Raffaele Hospital

Milan, Italy, 20132, Italy

Location

Related Publications (4)

• 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.

  PMID: 20889035 BACKGROUND

• 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.

  PMID: 32560482 BACKGROUND

• 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.

  PMID: 37443027 BACKGROUND

• 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.

  PMID: 7785800 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 26, 2025
• Study Start: April 8, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

IT (1)