Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
Primary Purpose
Jaw, Edentulous, Partially
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
Sponsored by
About this trial
This is an interventional treatment trial for Jaw, Edentulous, Partially
Eligibility Criteria
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
Sites / Locations
- Dept. of Implant Dentistry, New York University
- Dept. of Prosthodontics, School of Dentistry, University of North Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ASTRA TECH Implant System; Fixture ST
Biomet 3i; Osseotite® Implants
Arm Description
Ø 4.5 cm in lengths 9-13 mm
Ø 4.0 cm in lengths 8.5-13 mm
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00746187
First Posted
September 2, 2008
Last Updated
March 14, 2016
Sponsor
Dentsply Sirona Implants and Consumables
1. Study Identification
Unique Protocol Identification Number
NCT00746187
Brief Title
Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
Official Title
An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dentsply Sirona Implants and Consumables
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASTRA TECH Implant System; Fixture ST
Arm Type
Experimental
Arm Description
Ø 4.5 cm in lengths 9-13 mm
Arm Title
Biomet 3i; Osseotite® Implants
Arm Type
Experimental
Arm Description
Ø 4.0 cm in lengths 8.5-13 mm
Intervention Type
Device
Intervention Name(s)
ASTRA TECH Implant System; Fixture ST: Ø 4.5 cm in lengths of 9, 11 and 13 mm.
Intervention Type
Device
Intervention Name(s)
3i Osseotite® implant: Ø 4.0 in lengths of 8.5, 10, 11.5 and 13 mm
Primary Outcome Measure Information:
Title
Marginal Bone Level Changes
Description
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.
Time Frame
3 years after implant placement (baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis P Tarnow, D.D.S. Prof.
Organizational Affiliation
Dept. of Implant Dentistry, New York University (to March 2011)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stuart Froum, Dr
Organizational Affiliation
Dept. of Implant Dentistry, New York University (from March 2011)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Implant Dentistry, New York University
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Dept. of Prosthodontics, School of Dentistry, University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7450
Country
United States
12. IPD Sharing Statement
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Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
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