Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00711113
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : February 7, 2014
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Dentsply Sirona Implants

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Jaw, Edentulous, Partially
Intervention Device: OsseoSpeed™
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OsseoSpeed
Hide Arm/Group Description Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Period Title: Overall Study
Started 47
Completed 36
Not Completed 11
Reason Not Completed
Lost to Follow-up             9
Implant lost             2
Arm/Group Title OsseoSpeed
Hide Arm/Group Description Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
59  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
19
  59.4%
Male
13
  40.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
United States 30
Germany 2
1.Primary Outcome
Title Implant Survival Rate
Hide Description An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
Time Frame At 5 year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients), of these three implants failed during the 5 year follow-up period.
Arm/Group Title OsseoSpeed
Hide Arm/Group Description:
Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Overall Number of Participants Analyzed 32
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
80
Measure Type: Number
Unit of Measure: percentage of implants
96.25
2.Primary Outcome
Title Implant Stability
Hide Description Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (<60) indicate low stability, medium values (60-70) indicate medium stability and high values (>70) indicate high stability.
Time Frame At 1 year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 1-year follow-up, 32 patients were still in the study and thus evaluable for the analysis.
Arm/Group Title OsseoSpeed
Hide Arm/Group Description:
Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Overall Number of Participants Analyzed 32
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
80
Mean (Standard Deviation)
Unit of Measure: units on a scale
68.3  (6.7)
3.Primary Outcome
Title Marginal Bone Adaptation
Hide 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 follow-up visit were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.
Time Frame At baseline (loading) and at 5 year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis presented and this includes implants loaded 0 to 56 days from implant placement (80 implants in 32 patients). At 5-year follow-up, 27 patients were still in the study and thus evaluable for the analysis.
Arm/Group Title OsseoSpeed
Hide Arm/Group Description:
Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
Overall Number of Participants Analyzed 27
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
68
Mean (Standard Deviation)
Unit of Measure: Millimeter
0.3  (0.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OsseoSpeed
Hide Arm/Group Description Fixture Osseospeed Implants with diameter of 3.5, 4.0, 4.5 and 5.0 mm and lengths of 8, 9, 11, 13, 15 and 17 mm.
All-Cause Mortality
OsseoSpeed
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
OsseoSpeed
Affected / at Risk (%) # Events
Total   3/47 (6.38%)    
Cardiac disorders   
Heart attack  1/47 (2.13%)  2
Vascular disorders   
Subdural hematoma  1/47 (2.13%)  1
Blod clot in lower leg  1/47 (2.13%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OsseoSpeed
Affected / at Risk (%) # Events
Total   0/47 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Manager Global Clinical Operations
Organization: DENTSPLY Implants
Phone: +46313763500
Responsible Party: Dentsply Sirona Implants
ClinicalTrials.gov Identifier: NCT00711113     History of Changes
Other Study ID Numbers: YA-OSS-0001
First Submitted: July 7, 2008
First Posted: July 8, 2008
Results First Submitted: August 22, 2013
Results First Posted: February 7, 2014
Last Update Posted: February 7, 2014