Clinical trial NCT04532359: Measurement of Implant Stability by Resonance Frequency Analysis in Patients Treated for an Upper Aero-digestive Tract Cancer
Official title: STABICAN : Measurement of Implant Stability by Analysis of the Resonance Frequency in Patients Treated for Cancer of the Upper Aero-digestive Tract
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Upper aero-digestive tract Cancer
Dental implant placement
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with squamous cell carcinoma of the upper aero-digestive tract (oral cavity, oropharynx, hypopharynx) who are going to undergo a surgical intervention with placement of dental implant(s) in an irradiated area or in the microanastomosis fibula flap.

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.

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

Primary outcomes:
measure: Evolution of implant stability in patients treated for cancer of the upper aero-digestive tract between placement and 3 months after placement
timeFrame: At 3 months after implant placement
Secondary outcomes:
measure: Evaluation of the association between the type of bone (maxilla/mandible and fibula) and implant stability
timeFrame: At 3 months after implant placement
measure: Evaluation of the correlation between the irradiation dose received at the implant site and implant stability
timeFrame: At 3 months after implant placement
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Anne-Gaëlle CHAUX-BODARD, MD
role: PRINCIPAL_INVESTIGATOR
References: