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

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.

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.

Study Overview

• Status: Completed
• Conditions: Jaw, Edentulous, Partially
• Intervention / Treatment: Device: OsseoSpeed™ length 6 mm; Device: OsseoSpeed™ length 11 mm

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3010
      • School of Dental Science, University of Melbourne
• Netherlands
  • Apeldoorn, Netherlands, 7315
    • Praktijk De Mondhoek
• Sweden
  • Göteborg, Sweden, SE 405 30
    • Dept. of Parodontology, Göteborg University
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • King's College London Dental Institute at Guy's King's and St Thomas' Hospitals
• United States
  • California
    • Los Angeles, California, United States, 90089-0641
      • USC School of Dentistry
  • Iowa
    • Iowa City, Iowa, United States, 52242-1010
      • The University of Iowa, College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group-1, Implant length 6 mm; Subjects treated with OsseoSpeed™ implant, length: 6 mm	Device: OsseoSpeed™ length 6 mm; OsseoSpeed™ dental implant, length: 6 mm
Other: Group-2, Implant length 11 mm; Subjects treated with OsseoSpeed™ implant, length: 11 mm	Device: OsseoSpeed™ length 11 mm; OsseoSpeed™ dental implant, length: 11 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Implant Survival	Overall implant survival, measured on implant level	Evaluated 5 years after implant placement
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
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.
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.

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants and Consumables
• Investigators: Study Director: Anna-Karin Lundgren, Direktor Clinical Research, Dentsply Sirona Implants, Mölndal, SWEDEN

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 16, 2007
• First Submitted That Met QC Criteria: October 16, 2007
• First Posted (Estimate): October 17, 2007

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous; Jaw, Edentulous, Partially
• Other Study ID Numbers: YA-SHO-0001