A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading

This study is currently recruiting participants.
Verified April 2012 by Dentsply Implants
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT01340170
First received: April 21, 2011
Last updated: April 24, 2012
Last verified: April 2012

April 21, 2011
April 24, 2012
April 2011
April 2013   (final data collection date for primary outcome measure)
Marginal bone level [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
Marginal Bone Level alterations will be 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.
Same as current
Complete list of historical versions of study NCT01340170 on ClinicalTrials.gov Archive Site
  • Marginal Bone Level [ Time Frame: 3 months after baseline ] [ Designated as safety issue: No ]
    Marginal Bone Level alterations will be 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.
  • Implant survival [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
    Implant survival rate will be evaluated by both clinically and radiographically counting the number of remaining implants from implant placement to one year after loading.
Same as current
Not Provided
Not Provided
 
A Study Evaluating OsseoSpeed TX Using Different Drilling Protocols With Immediate Loading
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

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Edentulism
Device: OsseoSpeed TX
OsseoSpeed TX dental implants, 6-17 mm
  • Experimental: Soft bone drilling protocol
    A soft bone drilling protocol will be used in bone quality 3 and 4
    Intervention: Device: OsseoSpeed TX
  • Active Comparator: Standard drilling protocol
    A standard drilling protocol will be used in bone quality 1 and 2
    Intervention: Device: OsseoSpeed TX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
138
Not Provided
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Robert Corbé +46317763000
Italy
 
NCT01340170
YA-OTX-0002
Not Provided
Dentsply Implants
Dentsply Implants
Not Provided
Principal Investigator: Ruggero Rodriguez y Baena, Prof University of Pavia
Dentsply Implants
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP