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Orthodontic and Articular Effects of the One-Step No-Prep Protocol

Investigation of the Orthodontic and Articular Effects of the One-Step No-Prep Protocol

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07533240
Acronym
OSNPO
Enrollment
30
Registered
2026-04-16
Start date
2026-04-01
Completion date
2041-02-24
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Extrusion, Tooth Wear

Keywords

Localized tooth wear, Orthodontic tooth movement, Minimally invasive dentistry, PICN restorations

Brief summary

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.

Detailed description

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.

Interventions

RADIATIONLow-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.

Sponsors

Mainjot Amélie
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Localized tooth wear that will be treated, or has already been treated, using the OSNPO protocol. * Age 18 years or older. * Sufficient cognitive ability to understand the study procedures and complete the required assessments. * Ability to read and complete the study questionnaires in French. * Written informed consent provided.

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Three-dimensional orthodontic tooth movements (linear)Baseline and end of OSNPO treatment (approximately 1 month)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).
Three-dimensional orthodontic tooth movements (angular)Baseline and end of OSNPO treatment (approximately 1 month)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 required to re-establish functional occlusionBaseline and end of OSNPO treatment (approximately 1 month)Assessment of the duration needed to re-establish a functional occlusion following OSNPO, considering the initial posterior open bite and the orthodontic mechanics applied.
Occlusal contactsBaseline; 1 month; annually up to 5 years; and at 10 years.Assessment of the number of occlusal contacts
Occlusal contacts stabilityBaseline; 1 month; annually up to 5 years; and at 10 years.Assessment of the stability of occlusal contacts over time
Changes in vertical facial heightBaseline and end of OSNPO treatment (approximately 1 month)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.
Temporomandibular joint positionBaseline and end of OSNPO treatment (approximately 1 month)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.
Temporomandibular joint functionBaseline and end of OSNPO treatment (approximately 1 month)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)

Secondary

MeasureTime frameDescription
Clinical performance of PICN partial restorations1 month; annually up to 5 years; 10 years.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).
Longevity of PICN partial restorations1 month; annually up to 5 years; 10 years.Evaluation of the longevity of PICN bonded restorations, considering restoration thickness, based on survival (presence vs. failure).
Oral health-related quality of life (OHIP-49)Baseline; weekly during orthodontic treatment; 1 month; annually up to 5 years; 10 years.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
Musculoskeletal symptomsBaseline; 1 month; annually up to 5 years; 10 years.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).
Patient satisfaction1 monthAssessment 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).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026