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Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later

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ClinicalTrials.gov Identifier: NCT00711425
Recruitment Status : Completed
First Posted : July 8, 2008
Results First Posted : September 26, 2011
Last Update Posted : September 9, 2013
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 45
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 45 [1]
Completed 41
Not Completed 4
Reason Not Completed
Protocol Violation             1
Death             2
Lost to Follow-up             1
[1]
Implant placement in 45 patients. Implant loading (baseline) in 44 patients.
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 44
Hide Baseline Analysis Population Description
Per protocol analysis presented, this includes implants loaded 0 to 56 days from implant placement (134 implants in 44 patients).
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
57  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
22
  50.0%
Male
22
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants
United States 29
Germany 15
1.Primary Outcome
Title Implant Survival Rate
Hide Description An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be 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 (134 implants in 44 patients).
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 44
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
134
Measure Type: Number
Unit of Measure: Percentage of implants
100
2.Primary Outcome
Title Implant Stability
Hide Description Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.
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 (134 implants in 44 patients).At 1-year follow-up, 43 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 43
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
130
Mean (Standard Deviation)
Unit of Measure: ISQ
77.4  (7.1)
3.Primary Outcome
Title Marginal Bone Adaptation
Hide Description Marginal bone adaptation will be 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 will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.
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 (134 implants in 44 patients). At 5-year follow-up, 41 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 41
Overall Number of Units Analyzed
Type of Units Analyzed: Implants
123
Mean (Standard Deviation)
Unit of Measure: Millimeter
-0.05  (1.96)
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   17/45 (37.78%)    
Cardiac disorders   
HEART ATTACK  2/45 (4.44%)  2
Gastrointestinal disorders   
INTESTINAL PAIN  1/45 (2.22%)  1
Infections and infestations   
TOXAEMIA AT RIGHT FOOT  1/45 (2.22%)  1
Investigations   
PT HAD MRI, CT SCAN + COLON OSCOPY DUE TO PAIN ON R ABDOMEN  1/45 (2.22%)  1
Musculoskeletal and connective tissue disorders   
LOWER LUMBAR PAIN  1/45 (2.22%)  1
SHOULDER PAIN  1/45 (2.22%)  1
Renal and urinary disorders   
KIDNEY ABCESS  1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders   
BACTERIAL LUNG INFECTION LED TO COLLAPSED LUNG  1/45 (2.22%)  1
Surgical and medical procedures   
FLUID MASS REMOVED FROM LUNG AFTER INFECTION CLEARED  1/45 (2.22%)  1
HYSTERECTOMY  1/45 (2.22%)  1
HEART SURGERY (4 BYPASSES)  1/45 (2.22%)  1
INJECTIONS BECAUSE OF PAIN IN THE LUMBAR SPINE  1/45 (2.22%)  1
OPERATION, SECOND STENT  1/45 (2.22%)  1
CLEANSING OF FRONTAL SINUS  1/45 (2.22%)  1
CYSTECTOMIA, ABLATION OF WISDOM TEETH  1/45 (2.22%)  1
Vascular disorders   
AORTIC ANEURYSM  1/45 (2.22%)  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   0/45 (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: NCT00711425     History of Changes
Other Study ID Numbers: YA-OSS-0002
First Submitted: July 7, 2008
First Posted: July 8, 2008
Results First Submitted: June 7, 2011
Results First Posted: September 26, 2011
Last Update Posted: September 9, 2013