Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
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ClinicalTrials.gov Identifier: NCT00746187 |
Recruitment Status :
Completed
First Posted : September 3, 2008
Results First Posted : April 16, 2014
Last Update Posted : April 13, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Jaw, Edentulous, Partially | Device: 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 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open, Randomized Study to Compare Two Dental Implant Systems With Regard to Changes in Marginal Bone Level. |
Study Start Date : | December 2002 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: ASTRA TECH Implant System; Fixture ST
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. |
Experimental: Biomet 3i; Osseotite® Implants
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 |
- 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746187
United States, New York | |
Dept. of Implant Dentistry, New York University | |
New York, New York, United States, 10010 | |
United States, North Carolina | |
Dept. of Prosthodontics, School of Dentistry, University of North Carolina | |
Chapel Hill, North Carolina, United States, 27599-7450 |
Principal Investigator: | 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) |
Responsible Party: | Dentsply Sirona Implants |
ClinicalTrials.gov Identifier: | NCT00746187 |
Other Study ID Numbers: |
YA-MIC-0003 |
First Posted: | September 3, 2008 Key Record Dates |
Results First Posted: | April 16, 2014 |
Last Update Posted: | April 13, 2016 |
Last Verified: | March 2016 |
Jaw, Edentulous Jaw, Edentulous, Partially Mouth, Edentulous Mouth Diseases |
Stomatognathic Diseases Tooth Diseases Jaw Diseases Musculoskeletal Diseases |