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
1 other identifier
observational
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedStudy Start
First participant enrolled
February 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedOctober 15, 2021
October 1, 2021
2.8 years
August 26, 2020
October 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Interventions
Implant placement
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patient having difficulties speaking and understanding French
- Patient under tutorship or curatorship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Léon Bérard
Lyon, 69008, France
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Anne-Gaëlle CHAUX-BODARD, MD
Centre Leon Berard
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2020
First Posted
August 31, 2020
Study Start
February 5, 2021
Primary Completion
December 1, 2023
Study Completion
March 1, 2024
Last Updated
October 15, 2021
Record last verified: 2021-10