NCT00746187

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

April 16, 2014

Completed
Last Updated

April 13, 2016

Status Verified

March 1, 2016

Enrollment Period

8.5 years

First QC Date

September 2, 2008

Results QC Date

March 12, 2014

Last Update Submit

March 14, 2016

Conditions

Jaw, Edentulous, Partially

Outcome Measures

Primary Outcomes (1)

  • Marginal Bone Level Changes

    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.

    3 years after implant placement (baseline)

Study Arms (2)

ASTRA TECH Implant System; Fixture ST

EXPERIMENTAL

Ø 4.5 cm in lengths 9-13 mm

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

Biomet 3i; Osseotite® Implants

EXPERIMENTAL

Ø 4.0 cm in lengths 8.5-13 mm

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

Interventions

ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.DEVICE
ASTRA TECH Implant System; Fixture ST
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mmDEVICE
Biomet 3i; Osseotite® Implants

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. of Implant Dentistry, New York University

New York, New York, 10010, United States

Location

Dept. of Prosthodontics, School of Dentistry, University of North Carolina

Chapel Hill, North Carolina, 27599-7450, United States

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Results Point of Contact

Title
Senior Manager Global Clinical Research
Organization
DENTSPLY Implants
clinicalresearchmolndal@dentsply.com
+46313763500

Study Officials

  • Dennis P Tarnow, D.D.S. Prof.

    Dept. of Implant Dentistry, New York University (to March 2011)

    PRINCIPAL INVESTIGATOR

  • Stuart Froum, Dr

    Dept. of Implant Dentistry, New York University (from March 2011)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

December 1, 2002

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 13, 2016

Results First Posted

April 16, 2014

Record last verified: 2016-03

Locations

US(2)