CariesNCT07534423
Post-Debonding Finishing in Orthodontics
An observational study of Caries and Enamel Lesions, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
This study investigates clinical approaches to orthodontic debonding and post-debonding finishing, focusing on enamel preservation. An observational epidemiological survey was conducted among dental professionals to assess commonly used techniques, instruments, and complications. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Caries, Enamel Lesions
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population consists of dental professionals active in the field of orthodontics across Italy. The sample includes specialists and practitioners who perform orthodontic debonding and finishing procedures as part of their clinical routine.
Who may be able to join
- Professional Background: Must be a dental professional with specific clinical knowledge and practical skills required to perform orthodontic therapies.
- Specialization: Eligible participants must fall into one of the following categories: Orthodontist (Specialist), General Dentist with demonstrated clinical competence in orthodontics, Resident/Post-graduate student specializing in Orthodontics and Dentofacial Orthopedics.
Who cannot join
- Non-Orthodontic Professionals: Dental professionals who do not belong to the categories mentioned above are excluded, even if they work within the dental field.
- Lack of Specific Competence: Practitioners who do not possess the necessary clinical expertise to perform orthodontic debonding and finishing procedures.
- Incomplete Participation: Failure to provide informed consent or complete the mandatory sections of the epidemiological survey.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Sapienza università di Roma
Roma, RM, 00161
Fabrizio Guerra, 3283150627, prof.fabrizio.guerra@gmail.com
About this study
Official title: Post-Debonding Finishing: Analysis of Clinical Approaches for Maintaining Enamel Health
This study investigates clinical approaches to orthodontic debonding and post-debonding finishing, focusing on enamel preservation. An observational epidemiological survey was conducted among dental professionals to assess commonly used techniques, instruments, and complications. Results highlight variability in clinical protocols, with mechanical methods being the most widely adopted. The study emphasizes the importance of minimally invasive strategies to reduce enamel damage and improve patient outcomes.
Read the detailed description
This study explores orthodontic debonding and post-debonding finishing procedures, with particular emphasis on their impact on enamel integrity and long-term oral health. The study is an observational epidemiological investigation aimed at identifying current clinical practices, materials, and associated complications.
The research was conducted using an online questionnaire developed using Google Forms. The survey consisted of 23 questions (19 multiple-choice and 4 open-ended) and was distributed to dental professionals involved in orthodontic practice. Participants included orthodontists, general dentists with orthodontic experience, and orthodontic residents.
The questionnaire was structured into four sections: demographic and professional data, instruments and techniques used for debonding and polishing, clinical complications observed, and post-treatment management strategies. Inclusion criteria required professional involvement in orthodontic procedures and informed consent, while non-relevant dental professionals were excluded.
Data were anonymized and analyzed using spreadsheet software.
- Conditions
- Caries, Enamel Lesions
- Keywords
- Orthodontic, Enamel integrity, debonding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dentists | Dentists who deal with orthodontics and post-debonding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and Type of Iatrogenic Enamel Damage Post-Orthodontic Debonding
Evaluation of the frequency and nature of enamel alterations (e.g., fractures, scratches, or surface roughness) observed by practitioners following the removal of orthodontic brackets and residual resin. This measure assesses the clinical impact of different debonding and finishing protocols on enamel integrity. Higher scores indicate a worse outcome (higher frequency of iatrogenic damage)
Measured: At the completion of the orthodontic treatment (immediate post-debonding phase).
Frequency of Patient-Reported Dental Sensitivity and Pain
Assessment of the incidence of hypersensitivity (to thermal or tactile stimuli) and discomfort/pain reported by patients during or immediately after the debonding and finishing procedures.
Measured: From the start of the debonding procedure up to the first follow-up visit (typically within a few weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jan 2024
- Primary completion1 Apr 2026
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CariesStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Guerra, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534423
- Sponsor's protocol ID
- 2024
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janiszewska-Olszowska J, Szatkiewicz T, Tomkowski R, Tandecka K, Grocholewicz K. Effect of orthodontic debonding and adhesive removal on the enamel - current knowledge and future perspectives - a systematic review. Med Sci Monit. 2014 Oct 20;20:1991-2001. doi: 10.12659/MSM.890912.
PubMed 25327612
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Debonding Finishing: Analysis of Clinical Approaches for Maintaining Enamel Health
- ClinicalTrials.gov ID
- NCT07534423
- Acronym / sponsor ID
- 2024
- Conditions
- Caries, Enamel Lesions
- Keywords
- Orthodontic, Enamel integrity, debonding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 16 Apr 2026 (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.
This study investigates clinical approaches to orthodontic debonding and post-debonding finishing, focusing on enamel preservation. An observational epidemiological survey was conducted among dental professionals to assess commonly used techniques, instruments, and complications. Results highlight variability in clinical protocols, with mechanical methods being the most widely adopted. The study emphasizes the importance of minimally invasive strategies to reduce enamel damage and improve patient outcomes.
Detailed description
This study explores orthodontic debonding and post-debonding finishing procedures, with particular emphasis on their impact on enamel integrity and long-term oral health. The study is an observational epidemiological investigation aimed at identifying current clinical practices, materials, and associated complications.
The research was conducted using an online questionnaire developed using Google Forms. The survey consisted of 23 questions (19 multiple-choice and 4 open-ended) and was distributed to dental professionals involved in orthodontic practice. Participants included orthodontists, general dentists with orthodontic experience, and orthodontic residents.
The questionnaire was structured into four sections: demographic and professional data, instruments and techniques used for debonding and polishing, clinical complications observed, and post-treatment management strategies. Inclusion criteria required professional involvement in orthodontic procedures and informed consent, while non-relevant dental professionals were excluded.
Data were anonymized and analyzed using spreadsheet software.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dentists | – | –Dentists who deal with orthodontics and post-debonding |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of dental professionals active in the field of orthodontics across Italy. The sample includes specialists and practitioners who perform orthodontic debonding and finishing procedures as part of their clinical routine.
Key inclusion criteria (2 listed)
- Professional Background: Must be a dental professional with specific clinical knowledge and practical skills required to perform orthodontic therapies.
- Specialization: Eligible participants must fall into one of the following categories: Orthodontist (Specialist), General Dentist with demonstrated clinical competence in orthodontics, Resident/Post-graduate student specializing in Orthodontics and Dentofacial Orthopedics.
Key exclusion criteria (3 listed)
- Non-Orthodontic Professionals: Dental professionals who do not belong to the categories mentioned above are excluded, even if they work within the dental field.
- Lack of Specific Competence: Practitioners who do not possess the necessary clinical expertise to perform orthodontic debonding and finishing procedures.
- Incomplete Participation: Failure to provide informed consent or complete the mandatory sections of the epidemiological survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and Type of Iatrogenic Enamel Damage Post-Orthodontic Debonding
Time frame: At the completion of the orthodontic treatment (immediate post-debonding phase).
Evaluation of the frequency and nature of enamel alterations (e.g., fractures, scratches, or surface roughness) observed by practitioners following the removal of orthodontic brackets and residual resin. This measure assesses the clinical impact of different debonding and finishing protocols on enamel integrity. Higher scores indicate a worse outcome (higher frequency of iatrogenic damage)
Frequency of Patient-Reported Dental Sensitivity and Pain
Time frame: From the start of the debonding procedure up to the first follow-up visit (typically within a few weeks).
Assessment of the incidence of hypersensitivity (to thermal or tactile stimuli) and discomfort/pain reported by patients during or immediately after the debonding and finishing procedures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 25327612Janiszewska-Olszowska J, Szatkiewicz T, Tomkowski R, Tandecka K, Grocholewicz K. Effect of orthodontic debonding and adhesive removal on the enamel - current knowledge and future perspectives - a systematic review. Med Sci Monit. 2014 Oct 20;20:1991-2001. doi: 10.12659/MSM.890912.
- Individual participant dataSharing planned: No
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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.
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 Caries and Enamel Lesions, run by University of Roma La Sapienza 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 2 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio Guerra (3283150627, fabrizio.guerra@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and Type of Iatrogenic Enamel Damage Post-Orthodontic Debonding (time frame: At the completion of the orthodontic treatment (immediate post-debonding phase).). The study lists 2 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 NCT07534423, which also lists 1 linked publication.
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 20 Apr 2026.