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OpenTrials
Completed

NCT Number: NCT01324778

Multi Centre Study Comparing OsseoSpeed TX With OsseoSpeed

To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Specialisttandvården, Hallands sjukhus, Halmstad, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of informed consent
  • Female/male aged 18 years and over
  • History of edentulism in the study area of at least 3 months
  • In need for implant(s) replacing missing tooth/teeth in the maxilla
  • Deemed by the investigator to be suitable for one stage surgery
  • Deemed by the investigator to be suitable for loading after 10-12 weeks
  • Deemed by the investigator as likely to present an initially stable implant situation.
  • Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants.

Exclusion criteria

  • Unlikely to be able to comply with study procedures, as judged by the investigator
  • Uncontrolled pathological processes in the oral cavity
  • Known or suspected current malignancy
  • History of radiation therapy in the head and neck region
  • History of chemotherapy within 5 years prior to surgery
  • Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
  • Uncontrolled diabetes mellitus
  • Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
  • Present alcohol and/or drug abuse
  • Current need for bone grafting and/or augmentation in the planned implant area
  • Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
  • Previous enrolment in the present study.
  • Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months.

Treatment and study plan

OsseoSpeed TX

Device

OsseoSpeedTM TX implants of lengths 6-17 mm

OsseoSpeed

Device

OsseoSpeedTM implants of lengths 6-17 mm

Primary outcomes

  1. Marginal Bone Level

    Time frame: One year after loading

    Marginal Bone Level will be 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. Marginal Bone Level expressed in millimeters at the 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).

Secondary outcomes

  1. Implant stability

    Time frame: At implant placement (inclusion) (day 1)

    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)

  2. Implant stability

    Time frame: At implant placement (inclusion) (day 1)

    Implant stability will be evaluated using Resonance Frequency Analysis (RFA)

  3. Implant stability

    Time frame: At implant loading (10-12 weeks after implant placement)

    Implant stability will be evaluated clinically/manually (recorded as stable yes/no)

  4. Implant survival

    Time frame: One year after loading

    Implant survival rate will be evaluated by clinically and radiographically counting the number of remaining implants from implant placement to one year after loading.

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Official study title

An Open, Randomized, Prospective Multi Centre Study Comparing OsseoSpeedTM TX With OsseoSpeedTM in the Partially and Totally Edentulous Maxillae

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Mar 29, 2011
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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