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

March 30, 2026 updated by: University of Liege

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Orthodontic Treatment with Aligners
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.
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.
Active Comparator: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at completion of treatment (approximately 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in buccal bone dehiscence
Time Frame: 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).
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 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)
Time Frame: Baseline and at completion of treatment (approximately 12 months)
Change in buccal bone thickness measured in millimeters using CBCT imaging.
Baseline and at completion of treatment (approximately 12 months)
Presence of bone fenestration
Time Frame: Baseline and at completion of treatment (approximately 12 months)
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
Time Frame: Baseline and at completion of treatment (approximately 12 months)
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
Time Frame: Baseline and at completion of treatment (approximately 12 months)
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
Time Frame: Baseline and at completion of treatment (approximately 12 months)
Change in daytime sleepiness assessed using the Epworth Sleepiness Scale questionnaire.
Baseline and at completion of treatment (approximately 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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