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Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.
This study has been completed.
Sponsor:
Dentsply Sirona Implants
Information provided by (Responsible Party):
Dentsply Sirona Implants
ClinicalTrials.gov Identifier:
NCT00746187
First received: September 2, 2008
Last updated: March 14, 2016
Last verified: March 2016
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Purpose
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.
| Condition | Intervention |
|---|---|
| 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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. |
Further study details as provided by Dentsply Sirona Implants:
Primary Outcome Measures:
- 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.
| Enrollment: | 36 |
| Study Start Date: | December 2002 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746187
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746187
Locations
| 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 | |
Sponsors and Collaborators
Dentsply Sirona Implants
Investigators
| 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) |
More Information
| Responsible Party: | Dentsply Sirona Implants |
| ClinicalTrials.gov Identifier: | NCT00746187 History of Changes |
| Other Study ID Numbers: |
YA-MIC-0003 |
| Study First Received: | September 2, 2008 |
| Results First Received: | March 12, 2014 |
| Last Updated: | March 14, 2016 |
Additional relevant MeSH terms:
|
Jaw, Edentulous Jaw, Edentulous, Partially Jaw Diseases Musculoskeletal Diseases |
Stomatognathic Diseases Mouth, Edentulous Mouth Diseases Tooth Diseases |
ClinicalTrials.gov processed this record on July 28, 2017