Overview

This trial is active, not recruiting.

Condition partial edentulism in the maxilla or in the mandible.
Treatments osseospeed ev, osseospeed tx
Sponsor Dentsply Implants
Start date November 2011
End date June 2018
Trial size 120 participants
Trial identifier NCT01528215, OTX-PLUS-0001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
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 implants; Ø 3.5, 4.0 and 5.0 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

Primary Outcomes

Measure
Marginal Bone Level
time frame: 12 months after implant loading

Secondary Outcomes

Measure
Marginal Bone Level
time frame: 6 months after implant loading
Marginal Bone Level
time frame: 24 months after implant loading
Marginal Bone Level
time frame: 36 months after implant loading
Marginal Bone Level
time frame: 48 months after implant loading
Marginal Bone Level
time frame: 60 months after implant loading

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

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.
Principal investigator Clark M Stanford, Prof
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Dentsply Implants.