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

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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Ellen BLANC; Phone Number: +33 4.78.78.2967; Email: ellen.blanc@lyon.unicancer.fr
• Study Contact Backup: Name: Anne-Gaëlle CHAUX-BODARD, MD; Phone Number: +33 4.78.78.29.59; Email: anne-gaelle.bodard@lyon.unicancer.fr

Study Locations

• France
  • Lyon, France, 69008
    • Recruiting
    • Centre Leon Berard
    • Contact: Anne-Gaëlle CHAUX-BODARD, MD; Phone Number: +33 4.78.78.29.59; Email: anne-gaelle.bodard@lyon.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Upper aero-digestive tract Cancer; Dental implant placement
• Other Study ID Numbers: STABICAN - ET20-099

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No