Assessment of Facial Symmetry After Facial Reconstruction Using Three-dimensional Stereophotogrammetry

NCT06534970 | Recruiting

• 2 other identifiers: RCAPHM23_0384ID RCB
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Facial reconstruction follows removal of a malignant or benign tumor of the oral cavity or face, complex facial trauma, or resection of osteonecrosis of the jaws. It\'s a challenge that aims to restore not only the functions of the face, but also its aesthetics, which is just as crucial. A poor aesthetic result after facial reconstruction has a serious impact on patient\'s lives. To develop more personalized surgery, and to anticipate and correct poor results in the future, it is essential to better understand the factors associated with poor aesthetic results in this type of surgery, as well as their impact on the patient\'s life. This means correctly assessing the aesthetic outcome of this surgery. Today, however, aesthetic evaluation criteria remain inadequate. A number of criteria are involved in facial attractiveness, and facial symmetry is a key factor. It is generally accepted that severe facial asymmetries considerably diminish facial attractiveness. Currently, aesthetic evaluation criteria (particularly symmetry) are based primarily on the subjective perception of the surgeon or patient. However, there is a need to be able to measure facial symmetry objectively. Methods for assessing symmetry rely on the placement of anatomical landmarks and the calculation of Euclidean distance, which involves locating homologous landmarks on each side of the face and comparing the length ratios of all possible lines connecting the landmarks on each side. However, these techniques are based on measurements often on two-dimensional (2D) photographs and do not take into account the three-dimensional nature of the face. Methods for three-dimensional analysis of facial symmetry have been developed based on three-dimensional CT reconstructions. However, this technique implies the use of an irradiating imaging technique, not systematically indicated at a distance from surgery. This study aims to validate a method for analyzing facial symmetry using three-dimensional stereophotogrammetry, to identify risk factors for facial asymmetry in patients who have undergone facial reconstruction, and to assess the impact of facial asymmetry on patients\' quality of life.

Conditions

Facial Reconstruction

Keywords

Three-dimensional stereophotogrammetry; Facial symmetry

Outcome Measures

Primary Outcomes (1)

• Correlation coefficient between root mean square deviation (RMSE) score and surgeon's assessment score

  Day 1

Secondary Outcomes (8)

• Intraclass Correlation Coefficient to assess intra-operator reproducibility

  Day 1

• Intraclass Correlation Coefficient to assess inter-operator reproducibility

  Day 1

• Demographic factors associated with objective facial asymmetry one year after facial reconstruction surgery

  Day 1

• Clinical factors associated with objective facial asymmetry one year after facial reconstruction surgery

  Day 1

• Therapeutic factors associated with objective facial asymmetry one year after facial reconstruction surgery

  Day 1

Study Arms (1)

Facial reconstruction patients

Reconstruction of the lower or middle third of the face using a pedicled flap or microanastomosed free flap following excision of a benign or malignant tumor of the oral cavity or face, osteonecrosis of the jaws, or traumatic loss of facial substance

Device: Three-dimensional stereophotogrammetry; Other: Questionnaires

Interventions

Three-dimensional stereophotogrammetry DEVICE

Three stereoscopic photographs

Facial reconstruction patients

Questionnaires OTHER

* SF-36 quality of life scale for general health inquiry * Rosenberg Self-Esteem Scale * Self-perception scale

Facial reconstruction patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent facial reconstruction, returning for consultation 1 year post-surgery.

You may qualify if:

• Male or female, 18 years of age or older,
• Patient having given non-opposition for participation in this study,
• Reconstruction of the lower or middle third of the face by pedicled flap or microanastomosed free flap following excision of a benign or malignant tumor of the oral cavity or face, osteonecrosis of the jaws, loss of facial traumatic substance,
• Surgery and routine follow-up performed in the 3 departments (maxillofacial surgery, ENT, plastic and reconstructive surgery) of the PROMOD cluster at Marseille's CHU Conception

You may not qualify if:

• History of reconstruction of the lower or middle third of the face other than that being evaluated at one year for this study,
• Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship, patients deprived of their liberty, pregnant or breast-feeding women),
• Persons who cannot read and understand the French language well enough to be able to give their non-opposition to participating in the research.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead
• Fondation des Gueules Cassées: collaborator

Study Sites (1)

Assistance Publique - Hôpitaux de Marseille

Marseille, 13005, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• CREMIEUX François

  AP-HM

  STUDY DIRECTOR

Central Study Contacts

Nicolas GRAILLON, MD

CONTACT

04 91 43 6319; nicolas.graillon@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: June 3, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

FR (1)