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Completed

NCT Number: NCT01528215

Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.

The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. The hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.

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Key information

Conditions

Partial Edentulism in the Maxilla or in the Mandible

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent, Dental School Department Periodontology, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of Informed Consent.
  • 18 -75 years at enrollment.
  • In need of implant(s) replacing missing tooth/teeth in the maxilla or in the mandible (no edentulous jaws).
  • History of edentulism in the planned implant area of at least 3 months (at Visit 2).
  • At least 4 months of healing after last grafting procedure in the planned implant area (at Visit 2).
  • Deemed by the investigator to be suitable for one stage surgery and be likely to present an initially stable implant situation i.e. have a bone height and bone width suitable for the chosen study implants.
  • Deemed by the investigator to be suitable for loading after 6-8 weeks.
  • Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants i.e. an even distribution of contacts between the teeth in the opposite jaw and the planned permanent crown/bridge.

Exclusion criteria

  • Unlikely to be able to comply with study procedures, as judged by the investigator.
  • Uncontrolled pathological processes in the oral cavity.
  • Untreated, uncontrolled caries and/or periodontal disease.
  • 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, as deemed by the investigator.
  • Uncontrolled diabetes mellitus.
  • Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration.
  • Smoking more than 10 cigarettes per day.
  • Present alcohol and/or drug abuse.
  • Current need for bone grafting and/or augmentation in the planned implant area. Local, minor soft tissue grafting will be allowed.
  • Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site).
  • Previous enrollment in the present study.
  • Simultaneous participation in other clinical studies at enrollment (Visit 1) and during the subject's first year of this study.

Treatment and study plan

OsseoSpeed EV

Device

OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm

OsseoSpeed TX

Device

OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm

Primary outcomes

  1. Marginal Bone Level Change After 1 Year in Use.

    Time frame: Evaluated at implant loading and at the 1 year follow-up after implant loading.

    Marginal bone level will be determined from radiographs and expressed as the distance 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 1 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.

Secondary outcomes

  1. Marginal Bone Level Change After 5 Years in Use.

    Time frame: Evaluated from implant loading to the 5 years follow-up after implant loading.

    Marginal bone level will be determined from radiographs and expressed as the distance 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 5 years follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Official study title

An Open, Prospective, Randomized, Multicenter Study Comparing OsseoSpeed™ EV With OsseoSpeed™ TX in Partially Edentulous Maxillae and Mandibles. A 5-year Follow-up Study.

Important dates

Study start
2011
Primary completion
2014
Study completion
2018
First posted
Feb 7, 2012
Registry last updated
Apr 22, 2020

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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