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NCT Number: NCT07513792

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

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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Key information

Conditions

Orthodontic Cone-Beam Computed Tomography Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Liege

Liège, Liege, 4000, Belgium

Location status: Recruiting

Location contact

Cyrielle Thonard

CONTACT

[email protected]

+3243233128

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Acronym: GOPRO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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