- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07534423
Post-Debonding Finishing in Orthodontics
Post-Debonding Finishing: Analysis of Clinical Approaches for Maintaining Enamel Health
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fabrizio Guerra
- Phone Number: 3283150627
- Email: fabrizio.guerra@uniroma1.it
Study Locations
-
-
RM
-
Roma, RM, Italy, 00161
- Recruiting
- Sapienza università di Roma
-
Contact:
- Fabrizio Guerra
- Phone Number: 3283150627
- Email: prof.fabrizio.guerra@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Dentists
Dentists who deal with orthodontics and post-debonding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
At the completion of the orthodontic treatment (immediate post-debonding phase).
|
|
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.
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From the start of the debonding procedure up to the first follow-up visit (typically within a few weeks).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024 (Other Grant/Funding Number: Rome Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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