Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.

Partial Edentulism in the Maxilla or in the Mandible Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528215
• Other study ID #: OTX-PLUS-0001
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: April 2018

Study information

• Verified date: April 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2018
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Partial Edentulism in the Maxilla or in the Mandible

Intervention

Device:
• OsseoSpeed EV
OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
• OsseoSpeed TX
OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm

Locations

Country	Name	City	State
Belgium	University Hospital Ghent, Dental School Department Periodontology	Ghent
Germany	Dep. of Prosthodontics, Goethe University	Frankfurt am Main
Italy	Dental private practice, Denis Cecchinato	Padova
United States	Dows Institute for Dental Research, University of Iowa, College of Dentistry	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Italy, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.