Measurement of Implant Stability by Resonance Frequency Analysis in Patients Treated for an Upper Aero-digestive Tract Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective is to describe the evolution of implant stability between the date of implant placement and 3 months later when the implant is implementated in patients treated for cancer of the upper aero-digestive tract

Detailed Description
-----------------
Oral implantology is widely used during prosthetic rehabilitation in healthy patients but also in patients presenting cancers of the upper aero-digestive tract. Systems for measuring implant stability using resonance frequency analysis exist and are used clinically by some practitioners, such as the Ostell® system from W&H. These systems make it possible to determine the osseointegration of the implant, and thus the appropriate time to insert the implant, by comparing the value obtained with average values. Implant survival rates are lower for implants placed in irradiated bone, with an implant stability quotient value identical to implant placement but lower after osseointegration. Only one study shows implant stability quotient values> 60 with a success rate of 100% at 41 months on implants placed in patients having received radiotherapy. However, no clinical study has investigated the kinetics of osseointegration and the stability of implants placed on a microanastomosis fibula flap as part of aesthetic and prosthetic reconstruction after cancer of the upper aero-digestive tract.

Official Title
-----------------
STABICAN : Measurement of Implant Stability by Analysis of the Resonance Frequency in Patients Treated for Cancer of the Upper Aero-digestive Tract

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: Implant placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with squamous cell carcinoma of the upper aero-digestive tract (oral cavity, oropharynx, hypopharynx Patient having been treated by external radiotherapy and/or having benefited from a microanastomosis fibula flap Patient going to undergo a surgical intervention with placement of dental implant(s) in an irradiated area or in the microanastomosis fibula flap Non-opposition to the study Exclusion Criteria: Patient having difficulties speaking and understanding French Patient under tutorship or curatorship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Implant placement|Implant placement|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of implant stability in patients treated for cancer of the upper aero-digestive tract between placement and 3 months after placement | Measure with Osstell Beacon device (Implant Stability Quotient : value from 1 to 100) | At 3 months after implant placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the association between the type of bone (maxilla/mandible and fibula) and implant stability | Correlation between the type of bone (maxilla / mandible and fibula) and implant stability | At 3 months after implant placement | 
| Evaluation of the correlation between the irradiation dose received at the implant site and implant stability | Correlation between the irradiation dose received at the implant site and implant stability | At 3 months after implant placement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper aero-digestive tract Cancer, Dental implant placement