Status:
COMPLETED
Study of Bone Preservation When OsseoSpeed™ Implants Are Placed Immediately Following Tooth Extraction
Lead Sponsor:
Dentsply Sirona Implants and Consumables
Conditions:
Jaw, Edentulous, Partially
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the clinical performance of implants placed in individuals who are about to loose one or more of their upper teeth. The main objective is to study how the surr...
Eligibility Criteria
Inclusion
- Provision of written informed consent
- At least 18 years at inclusion
- At least 20 teeth with expected functional balanced occlusion after restoration
- In need of one or more implants replacing teeth to be removed in the maxilla within region 15 to 25
- Presence of an intact extraction socket following removal of the natural tooth defined by: (1) a situation where the marginal border of the facial bone crest deviates less than or equal to 2 mm from that of the expected normal anatomy of the site/region, (2) a marginal border of a potential facial fenestration at least 3 mm apical of the marginal bone crest
- Presence of an extraction socket anatomy, following removal of the natural tooth, suitable for both cylindrical and conical/cylindrical implants
Exclusion
- Untreated rampant caries and uncontrolled periodontal disease
- Absence of adjacent (mesial and/or distal) natural tooth root
- Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent / non-insulin dependent Diabetes Mellitus)
- Current alcohol or drug abuse
- Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- Need for systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- History of radiation in the head and neck region
- History of chemotherapy within 5 years prior to surgery
- Unable or unwilling to return for follow-up visits for a period of 3 years and 6 months
- Unrealistic esthetic demands
- Unlikely to be able to comply with study procedures according to Investigators judgement
- Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the investigational site)
- Previous enrolment in this study
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2011
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00711282
Start Date
December 1 2005
End Date
June 14 2011
Last Update
February 6 2023
Active Locations (3)
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1
Studio Odontoiatrico
Padua, Italy, 351 25
2
Department of Periodontics, Faculty of Odontology, Universidad Complutense de Madrid
Madrid, Spain, 28040
3
Department of Periodontology, School of Dental Medicine, University of Berne
Bern, Switzerland, CH-3010