The Impact of a 3D Imaging Tool on Reducing Gum Recession During Orthodontic Treatment With Aligners
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D CBCT-Guided Orthodontic Treatment with Aligners, conventional orthodontic treatment planning.
- Who it may be relevant to
- Registry conditions: Orthodontic, Gingival Recession, Cone-Beam Computed Tomography. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of a 3D Imaging Visualization Tool for Orthodontic Treatment With Aligners in Reducing Periodontal Recession Occurrence
Overview
This study investigates whether using 3D imaging technology (Cone Beam Computed Tomography or CBCT) for orthodontic treatment planning with aligners can reduce the risk of gingival recession in adult patients seeking dental arch expansion. Many aligner treatments involve expanding the dental arches to address issues like crowding and "black corridors," but this can sometimes lead to gum recession. The research compares two groups of patients: one group will have their treatment planned using CBCT, which allows for detailed 3D visualization of the teeth and bone structure, while the other group will follow a conventional 2D treatment plan. The goal is to see if the 3D tool helps prevent gum recession and other periodontal problems like bone thinning, as well as to assess the impact on other factors like upper airway dimensions. The study is a randomized controlled trial with 40 participants. It will track changes in gum health, bone structure, and airway volume over the course of treatment. The researchers aim to find out if the advanced imaging tool provides significant benefits compared to traditional planning methods.
Interventions
- Device 3D CBCT-Guided Orthodontic Treatment with Aligners
This intervention involves orthodontic treatment with clear aligners, where the treatment planning is guided by Cone Beam Computed Tomography (CBCT). The CBCT data is integrated into the digital planning software to allow 3D visualization of teeth and surrounding bone structures. This enables precise planning of tooth movements within the bony envelope, aiming to reduce the risk of gingival recession and other periodontal complications associated with arch expansion. - Device conventional orthodontic treatment planning
Orthodontic treatment planning is traditionally based on two-dimensional radiographs (cephalometric and panoramic), which do not provide information about the three-dimensional position of teeth and their roots within the alveolar bone.
Primary outcome measures
- Change in total gingival recession severity score (S1 - S0) [Time frame: Baseline and at completion of treatment (approximately 12 months)]
Secondary outcome measures (7)
- Change in buccal bone dehiscence [Time frame: Baseline and at completion of treatment (approximately 12 months)]
- Change in keratinized tissue height [Time frame: Baseline and at completion of treatment (approximately 12 months)]
- Change in buccal bone thickness (mm) [Time frame: Baseline and at completion of treatment (approximately 12 months)]
- Presence of bone fenestration [Time frame: Baseline and at completion of treatment (approximately 12 months)]
- Change in upper airway volume [Time frame: Baseline and at completion of treatment (approximately 12 months)]
- Change in smallest transverse upper airway dimension [Time frame: Baseline and at completion of treatment (approximately 12 months)]
- Change in Epworth Sleepiness Scale score [Time frame: Baseline and at completion of treatment (approximately 12 months)]
Eligibility criteria
Inclusion criteria
- more than 18years old
- requesting an orthodontic treatment with aligners
- dental class I or slight class II or III
- presence of black corridors
Exclusion criteria
- agenesis or extraction except for the 3rd molars
- need of extraction for the orthodontic treatment-need for orthognathic surgery
- generalized unilateral, bilateral, or anterior crossbite
- active periodontal disease
- presence of severe recession (≥2mm)
- furcation involvement
- absence of keratinized tissues
- smoker > 10c/day-auto-immune disease or immunocompromised patients
- uncontrolled diabetes
- use of steroids or biphosphonates-local or systemic infection (medical treatment needed prior to entrance to the study)
- pregnancy
- alcoholism or chronically drug abuse
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- University of Liege — Liège
Identifiers
NCT: NCT07513792 · 2023/109