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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00545818




Registration number
NCT00545818
Ethics application status
Date submitted
16/10/2007
Date registered
17/10/2007
Date last updated
19/05/2020

Titles & IDs
Public title
Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
Scientific title
An Open, Prospective, Randomized, Multi-center Study Comparing OsseoSpeed™ Implant 6 mm With OsseoSpeed™ Implant 11 mm in the Posterior Maxilla and Mandible. A 5-year Follow-up Study.
Secondary ID [1] 0 0
YA-SHO-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Jaw, Edentulous, Partially 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - OsseoSpeed™ length 6 mm
Treatment: Devices - OsseoSpeed™ length 11 mm

Experimental: Group-1, Implant length 6 mm - Subjects treated with OsseoSpeed™ implant, length: 6 mm

Other: Group-2, Implant length 11 mm - Subjects treated with OsseoSpeed™ implant, length: 11 mm


Treatment: Devices: OsseoSpeed™ length 6 mm
OsseoSpeed™ dental implant, length: 6 mm

Treatment: Devices: OsseoSpeed™ length 11 mm
OsseoSpeed™ dental implant, length: 11 mm
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiological Assessments of Marginal Bone Level Alteration
Timepoint [1] 0 0
Evaluated from implant installation to 5 years follow-up after implant placement
Secondary outcome [1] 0 0
Overall Implant Survival
Timepoint [1] 0 0
Evaluated 5 years after implant placement
Secondary outcome [2] 0 0
Evaluation of the Periimplant Mucosa Condition - By Assessment BoP
Timepoint [2] 0 0
Measured at the 5-year follow-up visit after loading
Secondary outcome [3] 0 0
Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD
Timepoint [3] 0 0
Evaluated at implant loading and at the 5-year follow-up visit.
Secondary outcome [4] 0 0
Presence of Plaque
Timepoint [4] 0 0
Evaluated at the 5-year follow-up visit after loading.

Eligibility
Key inclusion criteria
* Provision of informed consent
* Aged 20-70 years at enrolment
* History of edentulism in the study area of at least four months
* Neighboring tooth/teeth to the planned bridge must have natural root(s)
* Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned bridge.
* Deemed by the investigator to have a bone height of at least 11 mm and a bone width of minimum 6 mm
* Deemed by the investigator as likely to present an initially stable implant situation
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unlikely to be able to comply with study procedures, as judged by the investigator
* Earlier graft procedures in the study area
* Uncontrolled pathologic processes in the oral cavity
* Known or suspected current malignancy
* History of radiation therapy in the head and neck region
* History of chemotherapy within 5 years prior to surgery
* Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
* Uncontrolled diabetes mellitus
* Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
* Smoking more than 10 cigarettes/day
* Present alcohol and/or drug abuse
* Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
* Previous enrolment in the present study.
* Severe non-compliance to protocol as judged by the investigator and/or Astra Tech
* Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
97
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
School of Dental Science, University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
Netherlands
State/province [3] 0 0
Apeldoorn
Country [4] 0 0
Sweden
State/province [4] 0 0
Göteborg
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Dentsply Sirona Implants and Consumables
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to see if OsseoSpeed™ implant 6 mm long is effective for rehabilitation of edentulism and if so, how it compares with OsseoSpeed™ implant 11 mm long. The primary hypothesis is that the alteration in bone level is equal in patients randomized to 6 mm as to patients randomized to 11 mm implants.
Trial website
https://clinicaltrials.gov/study/NCT00545818
Trial related presentations / publications
Gulje F, Abrahamsson I, Chen S, Stanford C, Zadeh H, Palmer R. Implants of 6 mm vs. 11 mm lengths in the posterior maxilla and mandible: a 1-year multicenter randomized controlled trial. Clin Oral Implants Res. 2013 Dec;24(12):1325-31. doi: 10.1111/clr.12001. Epub 2012 Sep 3.
Zadeh HH, Gulje F, Palmer PJ, Abrahamsson I, Chen S, Mahallati R, Stanford CM. Marginal bone level and survival of short and standard-length implants after 3 years: An Open Multi-Center Randomized Controlled Clinical Trial. Clin Oral Implants Res. 2018 Aug;29(8):894-906. doi: 10.1111/clr.13341. Epub 2018 Jul 12.
Public notes

Contacts
Principal investigator
Name 0 0
Anna-Karin Lundgren
Address 0 0
Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00545818