Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis

Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00213837

Enrollment

Registered

2005-09-21

Start date

2003-10-31

Completion date

2008-09-30

Last updated

2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otorhinolaryngologic Diseases

Keywords

porous titanium implants, thyroplasty, vocal cord paralysis, male or female more than 18 years old

Brief 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 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.

Interventions

DEVICEMandibular prosthesis made of a new highly biointegratable material

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female more than 18 years old

Exclusion criteria

* Age less than 18 years old * Pregnant women * Local carcinoma excluding radiotherapic or surgical control * Poor general condition * Contraindication to general anesthesia * Uncontrolled diabetes

Design outcomes

Primary

Measure	Time frame
TEP scan + MRI + CT scan	3 months after surgery
Blood analysis (interleukin)	8, 15, 30 days and 3 months after surgery
All types of complication	8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026