NCT07534423

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2024Jun 2026

Study Start

First participant enrolled

January 1, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

DebondingPost-debonding

Keywords

debondingPost-debondigOrthodonticEnamel integrity

Outcome Measures

Primary Outcomes (2)

  • 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)

    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.

    From the start of the debonding procedure up to the first follow-up visit (typically within a few weeks).

Study Arms (1)

Dentists

Dentists who deal with orthodontics and post-debonding

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza università di Roma

Roma, RM, 00161, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25327612BACKGROUND

Central Study Contacts

Fabrizio Guerra

CONTACT

3283150627fabrizio.guerra@uniroma1.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, MD, pHd

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

January 1, 2024

Primary Completion

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)