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Virtual planning may improve quality of life after jaw reconstruction

NCT ID NCT04725396

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

132 people

The number who actually took part.

Started

Apr 2021

Finished

Oct 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • CHR de Valenciennes

    Valenciennes, France

  • CHU Groupe Hospitalier Pellegrin

    Bordeaux, 33076, France

  • CHU Gui de Chauliac

    Montpellier, France

  • CHU Hotel Dieu

    Nantes, France

  • CHU Pontchaillou

    Rennes, France

  • Centre Antoine Lacassagne

    Nice, 06 103, France

  • Centre François Baclesse

    Caen, France

  • Centre Oscar Lambret

    Lille, France

  • Gustave Roussy

    Villejuif, France

  • IUCT-O

    Toulouse, France

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