Orthodontic ApplianceNCT07304310
Comparison of Two Orthodontic Clean-Up Protocols
An observational study of Orthodontic Appliance and Debonding, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Orthodontic clean-up following debonding remains a technically demanding procedure, with documented risks of enamel roughening, microdefects, discoloration, and increased plaque retention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthodontic Appliance, Debonding, Case-control Study
- What is being tested?
- Two-step ultrasonic protocol and One-step clean-up protocol
- Type of treatment
- Medical device
- How many people
- 142 participants
- Where
- 1 siteItaly
- Study dates
- 8 Apr 2025to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients treated with removable orthodontic appliances
- Patients whose debonding exceeded 24 months
- ICDAS-II score > 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Orthodontic Appliance, Debonding, Case-control Study
- Being tested
- Two-step ultrasonic protocol, One-step clean-up protocol
- Keywords
- orthodontic clean-up, orthodontic debonding, enamel preservation, minimally invasive dentistry, case-control study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-step ultrasonic protocolDevice
Diamond- and PEEK-coated inserts
One-step clean-up protocolDevice
One-step tungsten carbide/abrasive polisher
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Two-step ultrasonic protocol | |
| Control group | Patients underwent orthodontic clean-up with a one-step tungsten carbide/abrasive polisher (One Gloss®, Shofu) Receives: Device: One-step clean-up protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, after 30 days
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start8 Apr 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Orthodontic ApplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simona Tecco, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304310
- Sponsor's protocol ID
- OCUs
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 20889035D'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.
PubMed 32560482Thawaba 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.
PubMed 37443027Campbell PM. Enamel surfaces after orthodontic bracket debonding. Angle Orthod. 1995;65(2):103-10. doi: 10.1043/0003-3219(1995)0652.0.CO;2.
PubMed 7785800
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Two Minimally Invasive Protocols for Orthodontic Clean-Up: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07304310
- Acronym / sponsor ID
- OCUs
- Conditions
- Orthodontic Appliance, Debonding, Case-control Study
- Keywords
- orthodontic clean-up, orthodontic debonding, enamel preservation, minimally invasive dentistry, case-control study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Device: Two-step ultrasonic protocolPatients underwent orthodontic clean-up with a two-step ultrasonic system (Combi Touch, Mectron) equipped with 30-µm diamond-coated and PEEK-coated inserts |
| Control group | – | Device: One-step clean-up protocolPatients underwent orthodontic clean-up with a one-step tungsten carbide/abrasive polisher (One Gloss®, Shofu) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients treated with removable orthodontic appliances
- Patients whose debonding exceeded 24 months
- ICDAS-II score > 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Two-step ultrasonic protocolDiamond- and PEEK-coated inserts | Device | Case group |
| One-step clean-up protocolOne-step tungsten carbide/abrasive polisher | Device | Control group |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Orthodontic treatment modality
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Background: PubMed 20889035Pont 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.
- Background: PubMed 32560482D'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.
- Background: PubMed 37443027Thawaba 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.
- Background: PubMed 7785800Campbell PM. Enamel surfaces after orthodontic bracket debonding. Angle Orthod. 1995;65(2):103-10. doi: 10.1043/0003-3219(1995)0652.0.CO;2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthodontic Appliance and Debonding, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Control Record (PCR) (time frame: Baseline, after 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07304310, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.