Clinical trial NCT00545818: Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 97
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Radiological Assessments of Marginal Bone Level Alteration
timeFrame: Evaluated from implant installation to 5 years follow-up after implant placement
Secondary outcomes:
measure: Overall Implant Survival
timeFrame: Evaluated 5 years after implant placement
measure: Evaluation of the Periimplant Mucosa Condition - By Assessment BoP
timeFrame: Measured at the 5-year follow-up visit after loading
measure: Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD
timeFrame: Evaluated at implant loading and at the 5-year follow-up visit.
measure: Presence of Plaque
timeFrame: Evaluated at the 5-year follow-up visit after loading.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC School of Dentistry
state: California
city: Iowa City
country: United States
facility: The University of Iowa, College of Dentistry
state: Iowa
city: Melbourne
country: Australia
facility: School of Dental Science, University of Melbourne
state: Victoria
city: Apeldoorn
country: Netherlands
facility: Praktijk De Mondhoek
city: Göteborg
country: Sweden
facility: Dept. of Parodontology, Göteborg University
city: London
country: United Kingdom
facility: King's College London Dental Institute at Guy's King's and St Thomas' Hospitals
Study officials:
affiliation: Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN
name: Anna-Karin Lundgren
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.