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

Sponsor
Centre Leon Berard (Other)
Overall Status
Recruiting
CT.gov ID
NCT04532359
Collaborator
(none)
40
1
36.8
1.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Implant placement

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
STABICAN : Measurement of Implant Stability by Analysis of the Resonance Frequency in Patients Treated for Cancer of the Upper Aero-digestive Tract
Actual Study Start Date :
Feb 5, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

  1. Evaluation of the association between the type of bone (maxilla/mandible and fibula) and implant stability [At 3 months after implant placement]

    Correlation between the type of bone (maxilla / mandible and fibula) and implant stability

  2. Evaluation of the correlation between the irradiation dose received at the implant site and implant stability [At 3 months after implant placement]

    Correlation between the irradiation dose received at the implant site and implant stability

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Léon Bérard Lyon France 69008

Sponsors and Collaborators

  • Centre Leon Berard

Investigators

  • Principal Investigator: Anne-Gaëlle CHAUX-BODARD, MD, Centre Leon Berard

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT04532359
Other Study ID Numbers:
  • STABICAN - ET20-099
First Posted:
Aug 31, 2020
Last Update Posted:
Oct 15, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Leon Berard

Study Results

No Results Posted as of Oct 15, 2021