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

14. oktober 2021 oppdatert av: Centre Leon Berard

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

Studieoversikt

Status

Rekruttering

Forhold

Kreft

Intervensjon / Behandling

Enhet: Implant placement

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Forventet)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Ellen BLANC
Telefonnummer: +33 4.78.78.2967
E-post: ellen.blanc@lyon.unicancer.fr

Studer Kontakt Backup

Navn: Anne-Gaëlle CHAUX-BODARD, MD
Telefonnummer: +33 4.78.78.29.59
E-post: anne-gaelle.bodard@lyon.unicancer.fr

Studiesteder

Frankrike
- - Lyon, Frankrike, 69008
    - Rekruttering
    - Centre Léon Bérard
    - Ta kontakt med:
      
      Anne-Gaëlle CHAUX-BODARD, MD
      
      Telefonnummer: +33 4.78.78.29.59
      
      E-post: anne-gaelle.bodard@lyon.unicancer.fr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
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	Measure with Osstell Beacon device (Implant Stability Quotient : value from 1 to 100)	At 3 months after implant placement

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Evaluation of the association between the type of bone (maxilla/mandible and fibula) and implant stability Tidsramme: At 3 months after implant placement	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 Tidsramme: At 3 months after implant placement	Correlation between the irradiation dose received at the implant site and implant stability	At 3 months after implant placement

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Centre Leon Berard

Etterforskere

Hovedetterforsker: Anne-Gaëlle CHAUX-BODARD, MD, Centre Léon Bérard

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. februar 2021

Primær fullføring (Forventet)

1. desember 2023

Studiet fullført (Forventet)

1. mars 2024

Datoer for studieregistrering

Først innsendt

26. august 2020

Først innsendt som oppfylte QC-kriteriene