Virtual planning may improve quality of life after jaw reconstruction
NCT ID NCT04725396
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether using computer-based virtual planning before jaw reconstruction surgery improves patients' quality of life compared to standard surgery. 132 adults with oral or oropharyngeal cancer who needed a fibula free-flap reconstruction took part. The main goal was to measure oral health-related quality of life one year after surgery using a questionnaire.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Preoperative virtual planning (PVP) device
- What this could lead to
- If successful, virtual planning could improve oral health-related quality of life for patients needing jaw reconstruction after oral cancer surgery.
- What could go wrong
- This is a completed study with 132 participants, so results are available but may not show a clear benefit. Virtual planning adds time and cost, and benefits may be small or not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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132 people
The number who actually took part.
- Started
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Apr 2021
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 years or over 2. Primary or recurrent OOPC, histologically proven, requiring segmental mandibulectomy 3. Planned immediate fibula free flap MR to be performed at the same time as the tumor ablation by segmental mandibulectomy 4. MR requiring at least one osteotomy for contouring the flap (i.e. at least 2 bone fragments) 5. East Cooperative Oncology Group (ECOG) performance status 0 or 1 6. American Society of Anesthesiologists Physical Status (ASA) score 1, 2, or 3 7. Patients considered fit for surgery as decided by the multidisciplinary team 8. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures 9. Patients must be affiliated to a Social Security System (or equivalent) 10. Patients must have signed a written informed consent form prior to any trial specific procedures. If the patients are physically unable to give their written consent, a trusted person of their choice, not related to the investigator or the sponsor, can confirm in writing the patient's consent Exclusion Criteria: 1. Non resectable tumors (T4b primary tumor, non resectable metastatic lymph nodes) 2. Comorbidities factors that would contraindicate surgery (such as severe peripheral artery disease) 3. MR requiring no osteotomy for contouring the flap (i.e. one bone fragment) 4. Patients with distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g. CT thorax and upper abdomen or positron emission tomography (PET)-CT 5. Other uncontrolled malignancy 6. Serious, non-healing or dehiscing wound, active ulcer or ongoing bone fracture at the free-flap donor site 7. Patients unwilling or unable to comply with the medical follow-up required by the trial because of psychosocial, familial, social, or geographical reasons 8. Participation in another clinical study with an investigational medicinal product during the last 30 days prior to inclusion 9. Patients deprived of their liberty or under protective custody or guardianship
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHR de Valenciennes
Valenciennes, France
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CHU Groupe Hospitalier Pellegrin
Bordeaux, 33076, France
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CHU Gui de Chauliac
Montpellier, France
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CHU Hotel Dieu
Nantes, France
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CHU Pontchaillou
Rennes, France
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Centre Antoine Lacassagne
Nice, 06 103, France
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Centre François Baclesse
Caen, France
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Centre Oscar Lambret
Lille, France
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Gustave Roussy
Villejuif, France
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IUCT-O
Toulouse, France
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