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Study on OsseoSpeed™ TX Short Implants in a Chinese Population

1 oktober 2019 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Interventionell

Inskrivning (Faktisk)

45

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: OsseoSpeed™ TX implants
OsseoSpeed TX implants; Ø 4.0 mm, length 6 mm.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Marginal Bone Level Alteration
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Marginal Bone Level Alteration After 36 Months
Tidsram: 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
Tidsram: 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
Tidsram: 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).
Tidsram: 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).
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 februari 2011

Primärt slutförande (Faktisk)

1 mars 2016

Avslutad studie (Faktisk)

1 mars 2016

Studieregistreringsdatum

Först inskickad

2 maj 2011

Först inskickad som uppfyllde QC-kriterierna

2 maj 2011

Första postat (Uppskatta)

3 maj 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 oktober 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 oktober 2019

Senast verifierad

1 oktober 2019

Mer information

Termer relaterade till denna studie

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Delvis tandlös käke

Kliniska prövningar på OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)

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