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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Orthodontic Treatment with Aligners | Active Comparator | This intervention involves orthodontic treatment with clear aligners, where the treatment planning is based on traditional 2D radiographs without the use of advanced 3D imaging tools like CBCT. The aligners are used to expand the dental arch and address crowding or black corridors, but the treatment planning does not incorporate 3D visualization of the teeth and surrounding bone structures, relying instead on conventional diagnostic methods. |
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| CBCT-Guided Orthodontic Treatment with Aligners | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D CBCT-Guided Orthodontic Treatment with Aligners | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total gingival recession severity score (S1 - S0) | The primary endpoint is defined as the difference between the sum of gingival recession severity scores at baseline (S0) and post-treatment (S1). The total score ranges from 0 to 64. | Baseline and at completion of treatment (approximately 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in buccal bone dehiscence | Change in buccal bone dehiscence score assessed using CBCT imaging, based on a 5-grade scale (0-4). | Baseline and at completion of treatment (approximately 12 months) |
| Change in keratinized tissue height |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Liege | Recruiting | Liège | Liege | 4000 | Belgium |
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| conventional orthodontic treatment planning | Device | 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. |
|
Change in keratinized tissue height measured clinically and categorized into 4 grades (0-3).
| Baseline and at completion of treatment (approximately 12 months) |
| Change in buccal bone thickness (mm) | Change in buccal bone thickness measured in millimeters using CBCT imaging. | Baseline and at completion of treatment (approximately 12 months) |
| Presence of bone fenestration | Presence or absence of bone fenestration assessed using CBCT imaging (binary outcome: yes/no). | Baseline and at completion of treatment (approximately 12 months) |
| Change in upper airway volume | Change in upper airway volume measured using CBCT imaging and dedicated software analysis. | Baseline and at completion of treatment (approximately 12 months) |
| Change in smallest transverse upper airway dimension | Change in the smallest transverse dimension of the upper airway measured using CBCT imaging. | Baseline and at completion of treatment (approximately 12 months) |
| Change in Epworth Sleepiness Scale score | Change in daytime sleepiness assessed using the Epworth Sleepiness Scale questionnaire. | Baseline and at completion of treatment (approximately 12 months) |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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