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Study on OsseoSpeed™ TX Short Implants in a Chinese Population

1. oktober 2019 oppdatert av: Dentsply Sirona Implants and Consumables

An Open, Prospective, Multi-center Study Assessing the OsseoSpeed™ TX Length 6 mm in in the Posterior Maxilla and Mandible. A 3-years Follow-up Study.

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 6 mm implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible and maxilla up to 3 years after loading. The hypothesis is that one stage surgery using 6 mm OsseoSpeed™ TX implant in the posterior region is safe and predictable.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

45

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Kina
      • Beijing, Kina, 100081
        • Department of Periodontology, School of Stomatology, Peking University
      • Beijing, Kina
        • Department of Implantology, School of Stomatology, Peking University
      • Beijing, Kina
        • Second Dental and Periodontal Center, School of Stomatology, Peking University

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

20 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion criteria:

  1. Provision of informed consent
  2. Female and male aged 20-75 years at enrolment
  3. In need for 2-3 implants in either side of the posterior mandible or maxilla (premolar and molar region)
  4. History of edentulism in the study area of at least four months
  5. Neighboring tooth/teeth to the planned bridge/crowns must have natural root(s)
  6. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge/crowns
  7. Deemed by the investigator to be suitable for implants of 6 mm length and to have a bone height of at least 6 mm and a bone width of minimum 6 mm
  8. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion criteria:

  1. Unlikely to be able to comply with study procedures, as judged by the investigator
  2. Earlier graft procedures in the study area
  3. Uncontrolled pathologic processes in the oral cavity
  4. Known or suspected current malignancy
  5. History of radiation therapy in the head and neck region
  6. History of chemotherapy within 5 years prior to surgery
  7. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
  8. Uncontrolled diabetes mellitus
  9. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
  10. Smoking more than 10 cigarettes/day
  11. Present alcohol and/or drug abuse
  12. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
  13. Previous enrolment in the present study
  14. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months
  15. Subjects that are unable to give informed consent

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: OsseoSpeed™ TX implants
OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.
Enhet: OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Marginal Bone Level Alteration
Tidsramme: Evaluated from implant installation to 12 months after implant loading

Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading.

Positive value = bone gain, Negative values = bone loss.
Evaluated from implant installation to 12 months after implant loading

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Marginal Bone Level Alteration After 36 Months
Tidsramme: Evaluated from implant loading to 36 months after implant loading.

Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 36 months after loading.

Positive value = bone gain, Negative values = bone loss.
Evaluated from implant loading to 36 months after implant loading.
Implant Survival
Tidsramme: Evaluated from implant installation to 36 months after implant loading.
Implant survival rate evaluated clinically and radiographically.
Evaluated from implant installation to 36 months after implant loading.
Implant Stability
Tidsramme: Evaluated 36 months after implant loading.
Implant stability evaluated clinically/manually (recorded as stable yes/no).
Evaluated 36 months after implant loading.
Condition of the Periimplant Mucosa (PPD).
Tidsramme: Evaluated from implant loading to 36 months after implant loading.

Condition of the periimplant mucosa measured by assessment of probing pocket depth (PPD).

Change in pocket depth expressed in millimeters at the 36 month follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).

Negative value = increased pocket depth
Evaluated from implant loading to 36 months after implant loading.
Condition of the Periimplant Mucosa (BoP).
Tidsramme: Evaluated from implant loading to 36 months after implant loading.

Condition of the periimplant mucosa will be measured by assessment of bleeding on probing (BoP).

Presented as % of the implants that show presence of bleeding at time of the 36 months follow-up.
Evaluated from implant loading to 36 months after implant loading.
Plaque
Tidsramme: Evaluated 36 months after implant loading.
Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit.
Evaluated 36 months after implant loading.
Crown-to-implant Ratio
Tidsramme: 12 months after implant loading
Crown height measured radiographically from the implant-abutment interface to the most coronal point on the prosthesis. The crown-to-implant ratio calculated from radiographs
12 months after implant loading

Samarbeidspartnere og etterforskere

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

Sponsor

Dentsply Sirona Implants and Consumables

Etterforskere

  • Hovedetterforsker: Huan Xin Meng, Prof, Department of Periodontology, School of Stomatology, Beijing University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

1. februar 2011

Primær fullføring (Faktiske)

1. mars 2016

Studiet fullført (Faktiske)

1. mars 2016

Datoer for studieregistrering

Først innsendt

2. mai 2011

Først innsendt som oppfylte QC-kriteriene

2. mai 2011

Først lagt ut (Anslag)

3. mai 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. oktober 2019

Sist bekreftet

1. oktober 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CHN-0005

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