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Clinical Trials/NCT04532359
NCT04532359
Unknown
N/A

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

Centre Leon Berard1 site in 1 country40 target enrollmentFebruary 5, 2021
ConditionsCancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
Centre Leon Berard
Enrollment
40
Locations
1
Primary Endpoint
Evolution of implant stability in patients treated for cancer of the upper aero-digestive tract between placement and 3 months after placement
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 5, 2021
End Date
March 1, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Evolution of implant stability in patients treated for cancer of the upper aero-digestive tract between placement and 3 months after placement

Time Frame: At 3 months after implant placement

Measure with Osstell Beacon device (Implant Stability Quotient : value from 1 to 100)

Secondary Outcomes

  • Evaluation of the association 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(At 3 months after implant placement)

Study Sites (1)

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