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OpenTrials
Completed

NCT Number: NCT00746187

Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.

The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.

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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

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Implant Dentistry, New York University, New York, United States

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 written informed consent
  • Age 18 - 75 years
  • Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid
  • Edentulous in the area/s if implant placement for more than 2 months

Exclusion criteria

  • Untreated caries and/or periodontal disease of residual dentition
  • Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.
  • Absence of occlusal stability in centric occlusion
  • Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
  • Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
  • Pregnancy
  • Present alcohol or drug abuse
  • Tobacco smoking during the last 6 months
  • Unable or unwilling to return for follow-up visits for a period of 3 years

Treatment and study plan

ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.

Device

3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm

Device

Primary outcomes

  1. Marginal Bone Level Changes

    Time frame: 3 years after implant placement (baseline)

    Marginal bone adaptation was expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at the 3-year follow-up visit were compared to values obtained at Implant placement (baseline). Positive value indicates bone gain and negative value bone loss.

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Official study title

An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.

Important dates

Study start
2002
Primary completion
2011
Study completion
2011
First posted
Sep 3, 2008
Registry last updated
Apr 13, 2016

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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