Facial ReconstructionSymFACENCT06534970
Assessment of Facial Symmetry After Facial Reconstruction Using Three-dimensional Stereophotogrammetry
An observational study of Facial Reconstruction, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Reconstruction
- What is being tested?
- Three-dimensional stereophotogrammetry and Questionnaires
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2025to Jun 2027
- Phase
- Observational
- 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
Study population: Patients who underwent facial reconstruction, returning for consultation 1 year to 5 years post-surgery.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux de Marseille
Marseille, 13005
Nicolas GRAILLON, MD, 04 91 43 63 19 ext. +33, nicolas.graillon@ap-hm.fr
Nicolas GRAILLON, MD
About this study
Official title: Development, Validation and Clinical Application of a Method for Quantitative 3D Assessment of Facial Symmetry After Facial Reconstruction Using Three-dimensional Stereophotogrammetry
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.
Read more
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
- Being tested
- Three-dimensional stereophotogrammetry, Questionnaires
- Keywords
- Three-dimensional stereophotogrammetry, Facial symmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional stereophotogrammetryDevice
Three stereoscopic photographs
QuestionnairesOther
- SF-36 quality of life scale for general health inquiry
- Rosenberg Self-Esteem Scale
- Self-perception scale
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Three-dimensional stereophotogrammetry; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between root mean square deviation (RMSE) score and surgeon's assessment score
Measured: Day 1
Secondary outcomes (9)
Description of the Root Mean Square Error (RMSE) and associated parameters from the FACE sculptor® Vectra Analysis Module (minimum, maximum, median and mean) to characterize measurement distribution and detect potential anomalies
Measured: Day 1
Intraclass Correlation Coefficient to assess intra-operator reproducibility
Measured: Day 1
Intraclass Correlation Coefficient to assess inter-operator reproducibility
Measured: Day 1
Demographic factors associated with objective facial asymmetry one year to five years after facial reconstruction surgery
Measured: Day 1
Clinical factors associated with objective facial asymmetry one year to five years after facial reconstruction surgery
Measured: Day 1
Therapeutic factors associated with objective facial asymmetry one year to five years after facial reconstruction surgery
Measured: Day 1
Relationship between objective measurement of facial asymmetry and the patient's subjective assessment of perception (satisfaction and body image)
The patient perception score is assessed by a scale constructed by the investigative team.
Measured: Day 1
Relationship between objective measurement of facial asymmetry and the patient's quality of life
The patient quality of life score is assessed by the French-validated SF-36 quality of life scale for general health inquiry" (36 items).
Measured: Day 1
Relationship between objective measurement of facial asymmetry and patient self-esteem
The patient self-esteem score is assessed by the French-validated Rosenberg self-esteem scale (10 items).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start3 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial ReconstructionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation des Gueules Cassées
- Responsible party
- Sponsor
- Investigators
- CREMIEUX François, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534970
- Sponsor's protocol ID
- RCAPHM23_0384
- Other IDs
- ID RCB
- Acronym
- SymFACE
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Validation and Clinical Application of a Method for Quantitative 3D Assessment of Facial Symmetry After Facial Reconstruction Using Three-dimensional Stereophotogrammetry
- ClinicalTrials.gov ID
- NCT06534970
- Acronym / sponsor ID
- SymFACE / RCAPHM23_0384
- Conditions
- Facial Reconstruction
- Keywords
- Three-dimensional stereophotogrammetry, Facial symmetry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Collaborators
- Fondation des Gueules Cassées
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Aug 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial reconstruction patients | – | Device: Three-dimensional stereophotogrammetry, Other: QuestionnairesReconstruction 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent facial reconstruction, returning for consultation 1 year to 5 years post-surgery.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Three-dimensional stereophotogrammetryThree stereoscopic photographs | Device | Facial reconstruction patients |
| Questionnaires* SF-36 quality of life scale for general health inquiry * Rosenberg Self-Esteem Scale * Self-perception scale | Other | Facial reconstruction patients |
Primary outcome
Correlation coefficient between root mean square deviation (RMSE) score and surgeon's assessment score
Time frame: Day 1
9 secondary outcomes
Description of the Root Mean Square Error (RMSE) and associated parameters from the FACE sculptor® Vectra Analysis Module (minimum, maximum, median and mean) to characterize measurement distribution and detect potential anomalies
Time frame: Day 1
Intraclass Correlation Coefficient to assess intra-operator reproducibility
Time frame: Day 1
Intraclass Correlation Coefficient to assess inter-operator reproducibility
Time frame: Day 1
Demographic factors associated with objective facial asymmetry one year to five years after facial reconstruction surgery
Time frame: Day 1
Clinical factors associated with objective facial asymmetry one year to five years after facial reconstruction surgery
Time frame: Day 1
Therapeutic factors associated with objective facial asymmetry one year to five years after facial reconstruction surgery
Time frame: Day 1
Relationship between objective measurement of facial asymmetry and the patient's subjective assessment of perception (satisfaction and body image)
Time frame: Day 1
Relationship between objective measurement of facial asymmetry and the patient's quality of life
Time frame: Day 1
Relationship between objective measurement of facial asymmetry and patient self-esteem
Time frame: Day 1
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 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
CREMIEUX François study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Reconstruction, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 3 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 23 Sep 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 France. 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?
Contact Nicolas GRAILLON, MD (04 91 43 6319 ext. +33, nicolas.graillon@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient between root mean square deviation (RMSE) score and surgeon's assessment score (time frame: Day 1). 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 23 Sep 2026.