The Impact of a 3D Imaging Tool on Reducing Gum Recession During Orthodontic Treatment With Aligners
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Liege
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
more than 18years old
requesting an orthodontic treatment with aligners
dental class I or slight class II or III
presence of black corridors
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
3D CBCT-Guided Orthodontic Treatment with Aligners
DeviceThis 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.
conventional orthodontic treatment planning
DeviceOrthodontic 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Conventional Orthodontic Treatment with AlignersActive comparator 1 intervention
Group B: CBCT-Guided Orthodontic Treatment with AlignersActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and at completion of treatment (approximately 12 months)Secondary outcomes
1
Change in buccal bone dehiscence
Change in buccal bone dehiscence score assessed using CBCT imaging, based on a 5-grade scale (0-4).
Time frame
Baseline and at completion of treatment (approximately 12 months)2
Change in keratinized tissue height
Change in keratinized tissue height measured clinically and categorized into 4 grades (0-3).
Time frame
Baseline and at completion of treatment (approximately 12 months)3
Change in buccal bone thickness (mm)
Change in buccal bone thickness measured in millimeters using CBCT imaging.
Time frame
Baseline and at completion of treatment (approximately 12 months)4
Presence of bone fenestration
Presence or absence of bone fenestration assessed using CBCT imaging (binary outcome: yes/no).
Time frame
Baseline and at completion of treatment (approximately 12 months)Sponsors and contacts
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Source ClinicalTrials.gov