OrthodonticGOPRONCT07513792
The Impact of a 3D Imaging Tool on Reducing Gum Recession During Orthodontic Treatment With Aligners
A study testing 3D CBCT-Guided Orthodontic Treatment with Aligners and conventional orthodontic treatment planning in people with Orthodontic and Gingival Recession, run by University of Liege at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthodontic, Gingival Recession, Cone-Beam Computed Tomography
- What is being tested?
- 3D CBCT-Guided Orthodontic Treatment with Aligners and conventional orthodontic treatment planning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Sep 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than 18years old
- requesting an orthodontic treatment with aligners
- dental class I or slight class II or III
- presence of black corridors
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University of Liege
Liège, Liege, 4000
Cyrielle Thonard, +3243233128, cyrielle.thonard@chuliege.be
About this study
Official title: The Impact of a 3D Imaging Visualization Tool for Orthodontic Treatment With Aligners in Reducing Periodontal Recession Occurrence
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.
- Being tested
- 3D CBCT-Guided Orthodontic Treatment with Aligners, conventional orthodontic treatment planning
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D CBCT-Guided Orthodontic Treatment with AlignersDevice
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 planningDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: conventional orthodontic treatment planning |
| 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. Receives: Device: 3D CBCT-Guided Orthodontic Treatment with Aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at completion of treatment (approximately 12 months)
Secondary outcomes (7)
Change in buccal bone dehiscence
Change in buccal bone dehiscence score assessed using CBCT imaging, based on a 5-grade scale (0-4).
Measured: Baseline and at completion of treatment (approximately 12 months)
Change in keratinized tissue height
Change in keratinized tissue height measured clinically and categorized into 4 grades (0-3).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and at completion of treatment (approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start4 Sep 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513792
- Sponsor's protocol ID
- 2023/109
- Acronym
- GOPRO
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a 3D Imaging Visualization Tool for Orthodontic Treatment With Aligners in Reducing Periodontal Recession Occurrence
- ClinicalTrials.gov ID
- NCT07513792
- Acronym / sponsor ID
- GOPRO / 2023/109
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Orthodontic Treatment with Aligners | Active comparator | Device: conventional orthodontic treatment planningThis 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 AlignersThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- more than 18years old
- requesting an orthodontic treatment with aligners
- dental class I or slight class II or III
- presence of black corridors
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D CBCT-Guided Orthodontic Treatment with AlignersThis 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 | CBCT-Guided Orthodontic Treatment with Aligners |
| conventional orthodontic treatment planningOrthodontic 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. | Device | Conventional Orthodontic Treatment with Aligners |
Primary outcome
Change in total gingival recession severity score (S1 - S0)
Time frame: 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.
7 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D CBCT-Guided Orthodontic Treatment with Aligners and conventional orthodontic treatment planning in people with Orthodontic and Gingival Recession, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total gingival recession severity score (S1 - S0) (time frame: Baseline and at completion of treatment (approximately 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.