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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04532359
Acronym
STABICAN
Enrollment
40
Registered
2020-08-31
Start date
2021-02-05
Completion date
2024-03-01
Last updated
2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Upper aero-digestive tract Cancer, Dental implant placement

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.

Interventions

DEVICEImplant placement

Implant placement

Sponsors

Centre Leon Berard
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Evolution of implant stability in patients treated for cancer of the upper aero-digestive tract between placement and 3 months after placementAt 3 months after implant placementMeasure with Osstell Beacon device (Implant Stability Quotient : value from 1 to 100)

Secondary

MeasureTime frameDescription
Evaluation of the association between the type of bone (maxilla/mandible and fibula) and implant stabilityAt 3 months after implant placementCorrelation between the type of bone (maxilla / mandible and fibula) and implant stability
Evaluation of the correlation between the irradiation dose received at the implant site and implant stabilityAt 3 months after implant placementCorrelation between the irradiation dose received at the implant site and implant stability

Countries

France

Contacts

Primary ContactEllen BLANC
ellen.blanc@lyon.unicancer.fr+33 4.78.78.2967
Backup ContactAnne-Gaëlle CHAUX-BODARD, MD
anne-gaelle.bodard@lyon.unicancer.fr+33 4.78.78.29.59

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026