Overview

This trial is active, not recruiting.

Condition edentulism
Treatment osseospeed tx
Sponsor Dentsply Implants
Start date April 2011
End date December 2016
Trial size 202 participants
Trial identifier NCT01340170, YA-OTX-0002

Summary

The study objective is to establish that there is no statistical difference in marginal bone level change comparing a Standard drilling protocol with a Soft bone drilling protocol when using OsseoSpeed TX and immediate loading.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
A soft bone drilling protocol will be used in bone quality 3 and 4
osseospeed tx
OsseoSpeed TX dental implants, 6-17 mm
(Active Comparator)
A standard drilling protocol will be used in bone quality 1 and 2
osseospeed tx
OsseoSpeed TX dental implants, 6-17 mm

Primary Outcomes

Measure
Marginal bone level
time frame: 12 months after baseline

Secondary Outcomes

Measure
Marginal Bone Level
time frame: 3 months after baseline
Implant survival
time frame: 12 months after baseline

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Provision of informed consent 2. Female/male aged 18 years and over 3. History of edentulism in the study area of at least 3 months 4. At least 4 months healing after last grafting procedure in the study area 5. In need for implant treatment replacing one to four missing single tooth in positions 14-17, 24-27, 34-37 and 44-47 6. The study implant position must be surrounded by natural tooth roots, unless the implant will constitute the most distal dentition. 7. Deemed by the investigator to be suitable for one stage surgery 8. Deemed by the investigator to be suitable for immediate loading 9. Deemed by the investigator as likely to present an initially stable implant situation. 10. Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants. 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. Known or suspected current malignancy 4. History of radiation therapy in the head and neck region 5. History of chemotherapy within 5 years prior to surgery 6. Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration 7. Uncontrolled diabetes mellitus 8. Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration 9. Present alcohol and/or drug abuse 10. Current need for bone grafting and/or augmentation in the planned implant area 11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site) 12. Previous enrolment in the present study. 13. Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months.

Additional Information

Official title An Open, Non-randomized, Prospective Multi-centre Study Evaluating a Soft Bone Drilling Protocol for Single Tooth Restoration in the Posterior Area With Immediate Loading
Principal investigator Ruggero Rodriguez y Baena, Prof
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Dentsply Implants.