An interventional study of Low-dose Cone-Beam Computed Tomography in Tooth Wear and Orthodontic Extrusion, sponsored by Mainjot Amélie. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Mainjot Amélie · Not applicable, Interventional, and Basic science
This study investigates how the One-Step No-Prep protocol with orthodontic assistance affects dental and jaw function in adults treated for localized tooth wear. It focuses on the predictability and extent of orthodontic tooth movements, the impact on temporomandibular joint position and function, and the quality and long-term stability of the restored bite.
Participants will receive minimally invasive bonded restorations combined with simple orthodontic mechanics. The study will evaluate changes in tooth position, bite contacts, facial vertical height, and temporomandibular joint function using digital scans, low-dose 3D imaging, jaw-tracking, and clinical examinations. Patient comfort, function, and satisfaction will also be assessed through questionnaires.
The goal is to better understand how this conservative treatment performs over time.
This study evaluates the clinical, orthodontic, and functional outcomes of the One-Step No-Prep protocol with orthodontic assistance (OSNPO) in adult patients presenting with localized tooth wear. The OSNPO approach combines bonded restorations placed without tooth preparation and controlled orthodontic extrusion to re-establish posterior occlusion. Although the protocol has shown promising clinical results, several key aspects have not yet been quantified or documented systematically.
The study includes both prospective and retrospective participants treated at the University Hospital of Liège. Prospective cases undergo standardized digital assessments, including intraoral scanning, low-dose cone-beam CT, and 3D jaw-tracking, while retrospective cases contribute long-term clinical and occlusal data. Follow-up extends to 5 years, with an additional evaluation at 10 years.
The primary focus is to characterize the nature and magnitude of orthodontic tooth movements, the time required to regain full occlusion, and the short- and long-term stability of occlusal contacts after treatment. Additional analyses examine changes in vertical facial dimensions, as well as temporomandibular joint position and function before and after treatment. Secondary outcomes include the clinical performance of PICN restorations and patient-reported measures of comfort, function, esthetics, and quality of life.
By integrating digital imaging, functional analysis, and patient-centered outcomes, this study aims to clarify the biological mechanisms underlying OSNPO, identify predictors of treatment duration and stability, and support evidence-based use of this minimally invasive protocol in the management of tooth wear.
62 studies on the registry are indexed under Tooth Wear; 12 are open to participants now.
This study's planned enrollment of 30 is below the median of 49 across 41 interventional studies indexed under Tooth Wear.
Browse Tooth Wear studies →Mainjot Amélie is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants treated with the OSNPO protocol undergo additional diagnostic assessments performed specifically for research purposes after completion of their routine clinical treatment. These research-only procedures include: * a low-dose, large-field CBCT scan to evaluate tooth movements, vertical facial dimensions, and temporomandibular joint position; * a digital intraoral scan to document occlusal contacts and dental morphology; * a Modjaw 3D jaw-tracking recording to assess mandibular function and occlusal dynamics.
Radiation: Low-dose Cone-Beam Computed Tomography
Acquisition of a low-dose, large-field CBCT scan performed specifically for research purposes after completion of the OSNPO treatment, used to assess tooth movements, vertical facial dimensions, and temporomandibular joint position.
Three-dimensional orthodontic tooth movements (linear)
Quantification of three-dimensional dental movements induced by the OSNPO protocol, including linear changes assessed on cone-beam computed tomography. Unit of measure : Millimeters (mm).
Time frame: Baseline and end of OSNPO treatment (approximately 1 month)
Three-dimensional orthodontic tooth movements (angular)
Quantification of three-dimensional dental movements induced by the OSNPO protocol, including angular changes assessed on cone-beam computed tomography. Unit of measure : Degrees (°).
Time frame: Baseline and end of OSNPO treatment (approximately 1 month)
Time required to re-establish functional occlusion
Assessment of the duration needed to re-establish a functional occlusion following OSNPO, considering the initial posterior open bite and the orthodontic mechanics applied.
Time frame: Baseline and end of OSNPO treatment (approximately 1 month)
Occlusal contacts
Assessment of the number of occlusal contacts
Time frame: Baseline; 1 month; annually up to 5 years; and at 10 years.
Occlusal contacts stability
Assessment of the stability of occlusal contacts over time
Time frame: Baseline; 1 month; annually up to 5 years; and at 10 years.
Changes in vertical facial height
Assessment of the variation in vertical facial height induced by the OSNPO protocol, measured on cone-beam computed tomography. The assessment includes linear measurements between anatomical landmarks.
Time frame: Baseline and end of OSNPO treatment (approximately 1 month)
Temporomandibular joint position
Assessment of the changes in temporomandibular joint position following the OSNPO protocol. Joint position is evaluated using cone-beam computed tomography, with measurements between anatomical landmarks.
Time frame: Baseline and end of OSNPO treatment (approximately 1 month)
Temporomandibular joint function
Assessment of the changes in temporomandibular joint function following the OSNPO protocol assessed using the Modjaw jaw-tracking system. Functional evaluation includes three-dimensional mandibular dynamics recorded during different mandibular movements, captured in real time. Unit of measure : Movement amplitudes in millimeters (mm)
Time frame: Baseline and end of OSNPO treatment (approximately 1 month)
Clinical performance of PICN partial restorations
Evaluation of the clinical quality of PICN bonded restorations using standardized FDI (World Dental Federation) criteria, considering restoration thickness. Unit of measure : FDI score (1-5; higher scores indicate poorer performance).
Time frame: 1 month; annually up to 5 years; 10 years.
Longevity of PICN partial restorations
Evaluation of the longevity of PICN bonded restorations, considering restoration thickness, based on survival (presence vs. failure).
Time frame: 1 month; annually up to 5 years; 10 years.
Oral health-related quality of life (OHIP-49)
Evaluation of the impact of the OSNPO protocol on oral health-related quality of life measured with the OHIP-49 (Oral Health Impact Profile) questionnaire. Unit of measure : Scale 1-5; higher scores indicate worse quality of life
Time frame: Baseline; weekly during orthodontic treatment; 1 month; annually up to 5 years; 10 years.
Musculoskeletal symptoms
Evaluation of musculoskeletal discomfort related to the craniofacial, cervical and upper-body regions using the Nordic Musculoskeletal Questionnaire. Unit of measure : Nordic score (0-10 per region; higher scores indicate more severe symptoms).
Time frame: Baseline; 1 month; annually up to 5 years; 10 years.
Patient satisfaction
Assessment of patient satisfaction regarding comfort, esthetics, function, and overall experience with the OSNPO protocol. Unit of mesure : Satisfaction score (1-10; higher scores indicate greater satisfaction).
Time frame: 1 month
Plan to share: No
Start is estimated for Apr 2026; primary completion for Feb 2041, 178 months later.
Of 21 interventional studies with no phase under Tooth Wear, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 30. This study's planned 178 months is above that.
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