Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
142 participants
OBSERVATIONAL
2025-04-08
2025-09-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
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)
One-step clean-up protocol
One-step tungsten carbide/abrasive polisher
Interventions
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Two-step ultrasonic protocol
Diamond- and PEEK-coated inserts
One-step clean-up protocol
One-step tungsten carbide/abrasive polisher
Eligibility Criteria
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Inclusion Criteria
* Debonding procedure must not have occurred more than 24 months prior to evaluation
* ICDAS-II index ≤ 2
Exclusion Criteria
* Patients whose debonding exceeded 24 months
* ICDAS-II score \> 2
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Simona Tecco
Associate Professor
Locations
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Dental Clinic, IRCCS San Raffaele Hospital
Milan, Italy, Italy
Countries
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References
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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.
Other Identifiers
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OCUs
Identifier Type: -
Identifier Source: org_study_id