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
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Ellen BLANC
- Telefonnummer: +33 4.78.78.2967
- E-mail: ellen.blanc@lyon.unicancer.fr
Undersøgelse Kontakt Backup
- Navn: Anne-Gaëlle CHAUX-BODARD, MD
- Telefonnummer: +33 4.78.78.29.59
- E-mail: anne-gaelle.bodard@lyon.unicancer.fr
Studiesteder
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Lyon, Frankrig, 69008
- Rekruttering
- Centre Léon Bérard
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Kontakt:
- Anne-Gaëlle CHAUX-BODARD, MD
- Telefonnummer: +33 4.78.78.29.59
- E-mail: anne-gaelle.bodard@lyon.unicancer.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Evolution of implant stability in patients treated for cancer of the upper aero-digestive tract between placement and 3 months after placement
Tidsramme: At 3 months after implant placement
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Measure with Osstell Beacon device (Implant Stability Quotient : value from 1 to 100)
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At 3 months after implant placement
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Evaluation of the association between the type of bone (maxilla/mandible and fibula) and implant stability
Tidsramme: At 3 months after implant placement
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Correlation between the type of bone (maxilla / mandible and fibula) and implant stability
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At 3 months after implant placement
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Evaluation of the correlation between the irradiation dose received at the implant site and implant stability
Tidsramme: At 3 months after implant placement
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Correlation between the irradiation dose received at the implant site and implant stability
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At 3 months after implant placement
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Anne-Gaëlle CHAUX-BODARD, MD, Centre Léon Bérard
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- STABICAN - ET20-099
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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