Study Comparing OsseoSpeed™ Implants of Two Different Lengths in the Upper and Lower Posterior Jaw

Jaw, Edentulous, Partially Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545818
• Other study ID #: YA-SHO-0001
• Status: Completed
• Phase: N/A
• Start date: November 2007
• Est. completion date: May 2016

Study information

• Verified date: May 2020
• Source: Dentsply Sirona Implants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Device:
• OsseoSpeed™ length 6 mm
OsseoSpeed™ dental implant, length: 6 mm
• OsseoSpeed™ length 11 mm
OsseoSpeed™ dental implant, length: 11 mm

Locations

Country	Name	City	State
Australia	School of Dental Science, University of Melbourne	Melbourne	Victoria
Netherlands	Praktijk De Mondhoek	Apeldoorn
Sweden	Dept. of Parodontology, Göteborg University	Göteborg
United Kingdom	King's College London Dental Institute at Guy's King's and St Thomas' Hospitals	London
United States	The University of Iowa, College of Dentistry	Iowa City	Iowa
United States	USC School of Dentistry	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants

Countries where clinical trial is conducted

United States,  Australia,  Netherlands,  Sweden,  United Kingdom, 

References & Publications (2)

Guljé 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.12 — View Citation

Zadeh HH, Guljé 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 Au — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological Assessments of Marginal Bone Level Alteration	Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.; Marginal Bone Level expressed in millimeters at the 5 year follow-up visit compared to values obtained at delivery of temporary restoration i.e. loading (baseline).; Positive value = bone gain, Negative value = bone loss.	Evaluated from implant installation to 5 years follow-up after implant placement
Secondary	Overall Implant Survival	Overall implant survival, measured on implant level	Evaluated 5 years after implant placement
Secondary	Evaluation of the Periimplant Mucosa Condition - By Assessment BoP	Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as s count of implants that show presence of BoP.	Measured at the 5-year follow-up visit after loading
Secondary	Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in PPD	Condition of the periimplant mucosa by assessment of change in probing pocket depth (PPD).; Change in pocket depth expressed in millimeters at the 5-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).; Negative value = increased pocket depth.	Evaluated at implant loading and at the 5-year follow-up visit.
Secondary	Presence of Plaque	Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection.; A study position was considered as bleeding "yes" if at least one of the four surfaces around the implant showed presence of bleeding on probing.	Evaluated at the 5-year follow-up visit after loading.