The Impact of a 3D Imaging Tool on Reducing Gum Recession During Orthodontic Treatment With Aligners

NCT07513792 — Not applicable, Recruiting, 40 participants, University of Liege

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The Impact of a 3D Imaging Visualization Tool for Orthodontic Treatment With Aligners in Reducing Periodontal Recession Occurrence

Registry	NCT07513792, acronym GOPRO
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	40 (Estimated)
Sponsor	University of Liege (Other)
Conditions	Orthodontic, Gingival Recession, Cone-Beam Computed Tomography
Interventions	3D CBCT-Guided Orthodontic Treatment with Aligners, conventional orthodontic treatment planning (Device)
Dates	start 2025-09-04, primary completion 2027-05-01 (estimated), completion 2027-06-01 (estimated), first posted 2026-04-07, last updated 2026-04-07
Locations	1 site in Belgium

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Conventional Orthodontic Treatment with Aligners	Active comparator	Device: conventional orthodontic treatment planning	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.
CBCT-Guided Orthodontic Treatment with Aligners	Active comparator	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.

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.
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.

+Outcome measures

Primary outcomes

Change in total gingival recession severity score (S1 - S0) [Baseline and at completion of treatment (approximately 12 months)]: 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.

Secondary outcomes

Change in buccal bone dehiscence [Baseline and at completion of treatment (approximately 12 months)]: Change in buccal bone dehiscence score assessed using CBCT imaging, based on a 5-grade scale (0-4).
Change in keratinized tissue height [Baseline and at completion of treatment (approximately 12 months)]: Change in keratinized tissue height measured clinically and categorized into 4 grades (0-3).
Change in buccal bone thickness (mm) [Baseline and at completion of treatment (approximately 12 months)]: Change in buccal bone thickness measured in millimeters using CBCT imaging.
Presence of bone fenestration [Baseline and at completion of treatment (approximately 12 months)]: Presence or absence of bone fenestration assessed using CBCT imaging (binary outcome: yes/no).
Change in upper airway volume [Baseline and at completion of treatment (approximately 12 months)]: Change in upper airway volume measured using CBCT imaging and dedicated software analysis.
Change in smallest transverse upper airway dimension [Baseline and at completion of treatment (approximately 12 months)]: Change in the smallest transverse dimension of the upper airway measured using CBCT imaging.
Change in Epworth Sleepiness Scale score [Baseline and at completion of treatment (approximately 12 months)]: Change in daytime sleepiness assessed using the Epworth Sleepiness Scale questionnaire.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
University of Liege	Liège, Liege	Belgium	Recruiting