NCT07533240

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
180mo left

Started Apr 2026

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

March 4, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2041

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2041

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

14.9 years

First QC Date

March 4, 2026

Last Update Submit

April 14, 2026

Conditions

Tooth WearOrthodontic Extrusion

Keywords

Localized tooth wearOrthodontic tooth movementMinimally invasive dentistryPICN restorations

Outcome Measures

Primary Outcomes (8)

  • 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).

    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 (°).

    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.

    Baseline and end of OSNPO treatment (approximately 1 month)

  • Occlusal contacts

    Assessment of the number of occlusal contacts

    Baseline; 1 month; annually up to 5 years; and at 10 years.

  • Occlusal contacts stability

    Assessment of the stability of occlusal contacts over time

    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.

    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.

    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)

    Baseline and end of OSNPO treatment (approximately 1 month)

Secondary Outcomes (5)

  • Clinical performance of PICN partial restorations

    1 month; annually up to 5 years; 10 years.

  • Longevity of PICN partial restorations

    1 month; annually up to 5 years; 10 years.

  • Oral health-related quality of life (OHIP-49)

    Baseline; weekly during orthodontic treatment; 1 month; annually up to 5 years; 10 years.

  • Musculoskeletal symptoms

    Baseline; 1 month; annually up to 5 years; 10 years.

  • Patient satisfaction

    1 month

Study Arms (1)

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.

Radiation: Low-dose Cone-Beam Computed Tomography

Interventions

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.

Post-Treatment CBCT, Intraoral Scan, and Modjaw Assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liège

Liège, 4000, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 20847997BACKGROUND

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2026

First Posted

April 16, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

February 24, 2041

Study Completion (Estimated)

February 24, 2041

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)