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

L

Léon Bérard Center

Status

Unknown

Conditions

Cancer

Treatments

Device: Implant placement

Study type

Observational

Funder types

Other

Identifiers

NCT04532359
STABICAN - ET20-099

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Anne-Gaëlle CHAUX-BODARD, MD; Ellen BLANC

Data sourced from clinicaltrials.gov

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