Tooth WearOSNPONCT07533240
Orthodontic and Articular Effects of the One-Step No-Prep Protocol
A study testing Low-dose Cone-Beam Computed Tomography in people with Tooth Wear and Orthodontic Extrusion, run by Mainjot Amélie at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Wear, Orthodontic Extrusion
- What is being tested?
- Low-dose Cone-Beam Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2026to 24 Feb 2041
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Liège
Liège, 4000
Amélie Mainjot, +3243233106, a.mainjot@chuliege.be
About this study
Official title: Investigation of the Orthodontic and Articular Effects of the One-Step No-Prep Protocol
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.
Read the 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.
- Conditions
- Tooth Wear, Orthodontic Extrusion
- Being tested
- Low-dose Cone-Beam Computed Tomography
- Keywords
- Localized tooth wear, Orthodontic tooth movement, Minimally invasive dentistry, PICN restorations
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose Cone-Beam Computed TomographyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Post-Treatment CBCT, Intraoral Scan, and Modjaw Assessment | Experimental | 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. Receives: Radiation: Low-dose Cone-Beam Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 (°).
Measured: 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.
Measured: Baseline and end of OSNPO treatment (approximately 1 month)
Occlusal contacts
Assessment of the number of occlusal contacts
Measured: Baseline; 1 month; annually up to 5 years; and at 10 years.
Occlusal contacts stability
Assessment of the stability of occlusal contacts over time
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Baseline and end of OSNPO treatment (approximately 1 month)
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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).
Measured: 1 month
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 startApr 2026 (estimated)
- Primary completion24 Feb 2041 (estimated)
- Study completion24 Feb 2041 (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 Tooth WearStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mainjot Amélie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mainjot Amélie, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533240
- Sponsor's protocol ID
- B7072025000111
- Acronym
- OSNPO
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.
PubMed 20847997
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Orthodontic and Articular Effects of the One-Step No-Prep Protocol
- ClinicalTrials.gov ID
- NCT07533240
- Acronym / sponsor ID
- OSNPO / B7072025000111
- Conditions
- Tooth Wear, Orthodontic Extrusion
- Keywords
- Localized tooth wear, Orthodontic tooth movement, Minimally invasive dentistry, PICN restorations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mainjot AmélieUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- 24 Feb 2041 (estimated)
- Study completion
- 24 Feb 2041 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Treatment CBCT, Intraoral Scan, and Modjaw Assessment | Experimental | Radiation: Low-dose Cone-Beam Computed TomographyAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- No exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose Cone-Beam Computed TomographyAcquisition 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. | Radiation | Post-Treatment CBCT, Intraoral Scan, and Modjaw Assessment |
Primary outcome
Three-dimensional orthodontic tooth movements (linear)
Time frame: 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)
Time frame: 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 occlusion
Time frame: Baseline 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 contacts
Time frame: Baseline; 1 month; annually up to 5 years; and at 10 years.
Assessment of the number of occlusal contacts
Occlusal contacts stability
Time frame: Baseline; 1 month; annually up to 5 years; and at 10 years.
Assessment of the stability of occlusal contacts over time
Changes in vertical facial height
Time frame: Baseline 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 position
Time frame: Baseline 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 function
Time frame: Baseline 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)
5 secondary outcomes
Clinical performance of PICN partial restorations
Time frame: 1 month; annually up to 5 years; 10 years.
Longevity of PICN partial restorations
Time frame: 1 month; annually up to 5 years; 10 years.
Oral health-related quality of life (OHIP-49)
Time frame: Baseline; weekly during orthodontic treatment; 1 month; annually up to 5 years; 10 years.
Musculoskeletal symptoms
Time frame: Baseline; 1 month; annually up to 5 years; 10 years.
Patient satisfaction
Time frame: 1 month
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 16 Apr 2026.
- Background: PubMed 20847997Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.
- 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?
A study testing Low-dose Cone-Beam Computed Tomography in people with Tooth Wear and Orthodontic Extrusion, run by Mainjot Amélie at 1 site in Belgium.
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 5 inclusion and 1 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 16 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 Belgium. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-dimensional orthodontic tooth movements (linear) (time frame: Baseline and end of OSNPO treatment (approximately 1 month)). The study lists 8 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 NCT07533240, 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 16 Apr 2026.