Otorhinolaryngologic DiseasesPhase 2NCT00213837
Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis
A Phase 2 study testing Mandibular prosthesis made of a new highly biointegratable material in people with Otorhinolaryngologic Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This trial will study the reconstruction of the anterior part of the mandible and the adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free microanastomosed bone flaps that are often associated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otorhinolaryngologic Diseases
- What is being tested?
- Mandibular prosthesis made of a new highly biointegratable material
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2003to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- Male or female more than 18 years old
Who cannot join
- Age less than 18 years old
- Pregnant women
- Local carcinoma excluding radiotherapic or surgical control
- Poor general condition
- Contraindication to general anesthesia
- Uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
Strasbourg
About this study
Official title: Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery
This trial will study the reconstruction of the anterior part of the mandible and the adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free microanastomosed bone flaps that are often associated with important morbidity.
The implant is consolidated by two prolonged parallel plates of titanium, allowing their fixation to the bone, easy to fix in a short time.
- Conditions
- Otorhinolaryngologic Diseases
- Being tested
- Mandibular prosthesis made of a new highly biointegratable material
- Keywords
- porous titanium implants, thyroplasty, vocal cord paralysis, male or female more than 18 years old
- Medical subject headings
- Otorhinolaryngologic Diseases, Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular prosthesis made of a new highly biointegratable materialDevice
Replacement of mandibular bone after partial or total mandible resection,avoiding then bone grafting. The porous titanium prosthesis is implanted under general anaesthesia in laryngeal surgeries. Bone resection and prosthesis placement is performed during the same surgical intervention. The prosthesis is attached onto the healthy bone with surgical screws. Simultaneous grafting of vascularised tissues may be done if the prosthesis surrounding area has been strongly irradiated.
What is being measured
The primary outcome is the main question the study is designed to answer.
TEP scan + MRI + CT scan
Measured: 3 months after surgery
Blood analysis (interleukin)
Measured: 8, 15, 30 days and 3 months after surgery
All types of complication
Measured: 8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otorhinolaryngologic DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Debry, MD, Principal investigator, Hopitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213837
- Sponsor's protocol ID
- 3096
- Status last verified
- Dec 2025
- First submitted
- 13 Sep 2005
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Schultz P, Vautier D, Atallah I, Gentine A, Debry C. [Reconstruction of the anterior mandibule using a porous titanium implant: a case report]. Rev Laryngol Otol Rhinol (Bord). 2008;129(3):201-5. French.
PubMed 19694164
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery
- ClinicalTrials.gov ID
- NCT00213837
- Acronym / sponsor ID
- 3096
- Conditions
- Otorhinolaryngologic Diseases
- Keywords
- porous titanium implants, thyroplasty, vocal cord paralysis, male or female more than 18 years old
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- 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.
This trial will study the reconstruction of the anterior part of the mandible and the adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free microanastomosed bone flaps that are often associated with important morbidity.
The implant is consolidated by two prolonged parallel plates of titanium, allowing their fixation to the bone, easy to fix in a short time.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female more than 18 years old
Key exclusion criteria (6 listed)
- Age less than 18 years old
- Pregnant women
- Local carcinoma excluding radiotherapic or surgical control
- Poor general condition
- Contraindication to general anesthesia
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 |
|---|---|---|
| Mandibular prosthesis made of a new highly biointegratable materialReplacement of mandibular bone after partial or total mandible resection,avoiding then bone grafting. The porous titanium prosthesis is implanted under general anaesthesia in laryngeal surgeries. Bone resection and prosthesis placement is performed during the same surgical intervention. The prosthesis is attached onto the healthy bone with surgical screws. Simultaneous grafting of vascularised tissues may be done if the prosthesis surrounding area has been strongly irradiated. | Device | – |
Primary outcome
TEP scan + MRI + CT scan
Time frame: 3 months after surgery
Blood analysis (interleukin)
Time frame: 8, 15, 30 days and 3 months after surgery
All types of complication
Time frame: 8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 19694164Schultz P, Vautier D, Atallah I, Gentine A, Debry C. [Reconstruction of the anterior mandibule using a porous titanium implant: a case report]. Rev Laryngol Otol Rhinol (Bord). 2008;129(3):201-5. French.
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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. This study is not recruiting at the moment.
Christian Debry, MD principal investigator
Hopitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mandibular prosthesis made of a new highly biointegratable material in people with Otorhinolaryngologic Diseases, run by University Hospital, Strasbourg, France 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 22 Dec 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEP scan + MRI + CT scan (time frame: 3 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00213837, which also lists 1 linked publication.
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 22 Dec 2025.