Orthodontic and Articular Effects of the One-Step No-Prep Protocol
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMainjot Amélie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
No exclusion criteria.
Trial design
Design model
Single group
Treatments tested in this trial
Low-dose Cone-Beam Computed Tomography
RadiationAcquisition 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Post-Treatment CBCT, Intraoral Scan, and Modjaw AssessmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
Occlusal contacts
Assessment of the number of occlusal contacts
Time frame
Baseline; 1 month; annually up to 5 years; and at 10 years.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mainjot Amélie
Lead sponsor
Centre Hospitalier Universitaire de Liege
Sponsor institution
Source ClinicalTrials.gov