Study of Bone Preservation When OsseoSpeed™ Implants Are Placed Immediately Following Tooth Extraction
NCT ID: NCT00711282
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2005-12-31
2011-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
OsseoSpeed™
OsseoSpeed™ MicroThread™, diameters of 3.5 and 4.0 mm.
B
OsseoSpeed™
OsseoSpeed™ MicroThread™, diameters of 4.5 and 5.0 mm.
Interventions
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OsseoSpeed™
OsseoSpeed™ MicroThread™, diameters of 3.5 and 4.0 mm.
OsseoSpeed™
OsseoSpeed™ MicroThread™, diameters of 4.5 and 5.0 mm.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Dentsply Sirona Implants and Consumables
INDUSTRY
Responsible Party
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Locations
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Studio Odontoiatrico
Padua, , Italy
Department of Periodontics, Faculty of Odontology, Universidad Complutense de Madrid
Madrid, , Spain
Department of Periodontology, School of Dental Medicine, University of Berne
Bern, , Switzerland
Countries
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References
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Huynh-Ba G, Pjetursson BE, Sanz M, Cecchinato D, Ferrus J, Lindhe J, Lang NP. Analysis of the socket bone wall dimensions in the upper maxilla in relation to immediate implant placement. Clin Oral Implants Res. 2010 Jan;21(1):37-42. doi: 10.1111/j.1600-0501.2009.01870.x.
Tomasi C, Sanz M, Cecchinato D, Pjetursson B, Ferrus J, Lang NP, Lindhe J. Bone dimensional variations at implants placed in fresh extraction sockets: a multilevel multivariate analysis. Clin Oral Implants Res. 2010 Jan;21(1):30-6. doi: 10.1111/j.1600-0501.2009.01848.x.
Sanz M, Cecchinato D, Ferrus J, Pjetursson EB, Lang NP, Lindhe J. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla. Clin Oral Implants Res. 2010 Jan;21(1):13-21. doi: 10.1111/j.1600-0501.2009.01824.x. Epub 2009 Nov 18.
Ferrus J, Cecchinato D, Pjetursson EB, Lang NP, Sanz M, Lindhe J. Factors influencing ridge alterations following immediate implant placement into extraction sockets. Clin Oral Implants Res. 2010 Jan;21(1):22-9. doi: 10.1111/j.1600-0501.2009.01825.x. Epub 2009 Nov 13.
Sanz M, Cecchinato D, Ferrus J, Salvi GE, Ramseier C, Lang NP, Lindhe J. Implants placed in fresh extraction sockets in the maxilla: clinical and radiographic outcomes from a 3-year follow-up examination. Clin Oral Implants Res. 2014 Mar;25(3):321-327. doi: 10.1111/clr.12140. Epub 2013 Feb 25.
Cecchinato D, Lops D, Salvi GE, Sanz M. A prospective, randomized, controlled study using OsseoSpeed implants placed in maxillary fresh extraction socket: soft tissues response. Clin Oral Implants Res. 2015;26(1):20-7. doi: 10.1111/clr.12295. Epub 2013 Dec 2.
Other Identifiers
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YA-OSS-0009
Identifier Type: -
Identifier Source: org_study_id
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