Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.

An Open, Prospective, Randomized, Multicenter Study Comparing OsseoSpeed™ EV With OsseoSpeed™ TX in Partially Edentulous Maxillae and Mandibles. A 5-year Follow-up Study.

The purpose of this study is to evaluate the outcome of implant OsseoSpeed EV compared to implant OsseoSpeed TX with regards to marginal bone level changes and implant survival rate up to five years after implant loading. The hypothesis is that there will be no clinically relevant differences in marginal bone level alterations one year after functional loading.

Study Overview

• Status: Completed
• Conditions: Partial Edentulism in the Maxilla or in the Mandible
• Intervention / Treatment: Device: OsseoSpeed EV; Device: OsseoSpeed TX

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent, Dental School Department Periodontology
• Germany
  • Frankfurt am Main, Germany, 605 90
    • Dep. of Prosthodontics, Goethe University
• Italy
  • Padova, Italy, 351 25
    • Dental private practice, Denis Cecchinato
• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242-1010
      • Dows Institute for Dental Research, University of Iowa, College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provision of Informed Consent.
2. 18 -75 years at enrollment.
3. In need of implant(s) replacing missing tooth/teeth in the maxilla or in the mandible (no edentulous jaws).
4. History of edentulism in the planned implant area of at least 3 months (at Visit 2).
5. At least 4 months of healing after last grafting procedure in the planned implant area (at Visit 2).
6. Deemed by the investigator to be suitable for one stage surgery and be likely to present an initially stable implant situation i.e. have a bone height and bone width suitable for the chosen study implants.
7. Deemed by the investigator to be suitable for loading after 6-8 weeks.
8. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants i.e. an even distribution of contacts between the teeth in the opposite jaw and the planned permanent crown/bridge.

Exclusion Criteria:

1. Unlikely to be able to comply with study procedures, as judged by the investigator.
2. Uncontrolled pathological processes in the oral cavity.
3. Untreated, uncontrolled caries and/or periodontal disease.
4. Known or suspected current malignancy.
5. History of radiation therapy in the head and neck region.
6. History of chemotherapy within 5 years prior to surgery.
7. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration, as deemed by the investigator.
8. Uncontrolled diabetes mellitus.
9. Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration.
10. Smoking more than 10 cigarettes per day.
11. Present alcohol and/or drug abuse.
12. Current need for bone grafting and/or augmentation in the planned implant area. Local, minor soft tissue grafting will be allowed.
13. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site).
14. Previous enrollment in the present study.
15. Simultaneous participation in other clinical studies at enrollment (Visit 1) and during the subject's first year of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OsseoSpeed EV; OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm	Device: OsseoSpeed EV; OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
ACTIVE_COMPARATOR: OsseoSpeed TX; OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm	Device: OsseoSpeed TX; OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Level Change After 1 Year in Use.	Marginal bone level will be determined from radiographs and expressed as the distance 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 1 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.	Evaluated at implant loading and at the 1 year follow-up after implant loading.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Level Change After 5 Years in Use.	Marginal bone level will be determined from radiographs and expressed as the distance 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 years follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).	Evaluated from implant loading to the 5 years follow-up after implant loading.

Collaborators and Investigators

• Sponsor: Dentsply Sirona Implants
• Investigators: Principal Investigator: Clark M Stanford, Prof, University of Illinois at Chicago, College of Dentistry

Publications and helpful links

General Publications

• Stanford CM, Barwacz C, Raes S, De Bruyn H, Cecchinato D, Bittner N, Brandt J. Multicenter Clinical Randomized Controlled Trial Evaluation of an Implant System Designed for Enhanced Primary Stability. Int J Oral Maxillofac Implants. 2016 Jul-Aug;31(4):906-15. doi: 10.11607/jomi.4869.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: February 3, 2012
• First Submitted That Met QC Criteria: February 3, 2012
• First Posted (ESTIMATE): February 7, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: OTX-PLUS-0001