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Recruiting NCT06534970

NCT06534970 Assessment of Facial Symmetry After Facial Reconstruction Using Three-dimensional Stereophotogrammetry

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Clinical Trial Summary
NCT ID NCT06534970
Status Recruiting
Phase
Sponsor Assistance Publique Hopitaux De Marseille
Condition Facial Reconstruction
Study Type OBSERVATIONAL
Enrollment 50 participants
Start Date 2025-06-03
Primary Completion 2027-06

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Three-dimensional stereophotogrammetryQuestionnaires

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 50 participants in total. It began in 2025-06-03 with a primary completion date of 2027-06.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Contact & Investigator

Central Contact

Nicolas GRAILLON, MD

✉ nicolas.graillon@ap-hm.fr

📞 04 91 43 6319

Principal Investigator

CREMIEUX François

STUDY DIRECTOR

AP-HM

Frequently Asked Questions

Who can join the NCT06534970 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Facial Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06534970 currently recruiting?

Yes, NCT06534970 is actively recruiting participants. Contact the research team at nicolas.graillon@ap-hm.fr for enrollment information.

Where is the NCT06534970 trial being conducted?

This trial is being conducted at Marseille, France.

Who is sponsoring the NCT06534970 clinical trial?

NCT06534970 is sponsored by Assistance Publique Hopitaux De Marseille. The principal investigator is CREMIEUX François at AP-HM. The trial plans to enroll 50 participants.

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