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Completed

NCT Number: NCT00545818

Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw

The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.

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Key information

Conditions

Jaw, Edentulous, Partially Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dental Science, University of Melbourne, Melbourne, Victoria, Australia

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
  • Aged 20-70 years at enrolment
  • History of edentulism in the study area of at least four months
  • Neighboring tooth/teeth to the planned bridge must have natural root(s)
  • Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
  • Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 6 mm
  • Deemed by the investigator as likely to present an initially stable implant situation

Exclusion criteria

  • Unlikely to be able to comply with study procedures, as judged by the investigator
  • Earlier graft procedures in the study area
  • Uncontrolled pathologic 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 could compromise post-operative healing and/or osseointegration
  • Uncontrolled diabetes mellitus
  • Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
  • Smoking more than 10 cigarettes/day
  • Present alcohol and/or drug abuse
  • 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.
  • Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
  • Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months

Treatment and study plan

OsseoSpeed™ length 6 mm

Device

OsseoSpeed™ dental implant, length: 6 mm

OsseoSpeed™ length 11 mm

Device

OsseoSpeed™ dental implant, length: 11 mm

Primary outcomes

  1. Radiological Assessments of Marginal Bone Level Alteration

    Time frame: Evaluated from implant installation to 5 years follow-up after implant placement

    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.

    Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline).

    Positive value = bone gain, Negative value = bone loss.

Secondary outcomes

  1. Overall Implant Survival

    Time frame: Evaluated 5 years after implant placement

    Overall implant survival, measured on implant level

  2. Evaluation of the Periimplant Mucosa Condition - By Assessment BoP

    Time frame: Measured at the 5-year follow-up visit after loading

    Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP.

  3. Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD

    Time frame: Evaluated at implant loading and at the 5-year follow-up visit.

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

    Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).

    Negative value = increased pocket depth.

  4. Presence of Plaque

    Time frame: Evaluated at the 5-year follow-up visit after loading.

    Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection.

    A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing.

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Official study title

An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2007
Registry last updated
May 19, 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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