Study of Bone Preservation When OsseoSpeed™ Implants Are Placed Immediately Following Tooth Extraction
February 3, 2023 updated by: Dentsply Sirona Implants and Consumables
A Prospective, Randomized, Controlled Study to Evaluate Buccal Bone Preservation Using Fixture MicroThread™ OsseoSpeed™ Placed in Fresh Extraction Sockets the Maxilla.
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 surrounding bone tissue reacts to two different shapes of implants.
Clinical performance, in wider terms, means esthetics and long lasting function.
Half of the patients will receive a cylindrically shaped implant and the other half will receive a conical-cylindrical implant.
The implants will be placed and after a healing period of 16 weeks the gum will be re-opened and the bone tissue response clinically evaluated.
Permanent artificial tooth/teeth will be attached six weeks after that.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Padova, Italy, 351 25
- Studio Odontoiatrico
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Madrid, Spain, 28040
- Department of Periodontics, Faculty of Odontology, Universidad Complutense de Madrid
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Berne, Switzerland, CH-3010
- Department of Periodontology, School of Dental Medicine, University of Berne
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: B
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OsseoSpeed™ MicroThread™, diameters of 3.5 and 4.0 mm.
OsseoSpeed™ MicroThread™, diameters of 4.5 and 5.0 mm.
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EXPERIMENTAL: A
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OsseoSpeed™ MicroThread™, diameters of 3.5 and 4.0 mm.
OsseoSpeed™ MicroThread™, diameters of 4.5 and 5.0 mm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Clinical measure of the thickness of the facial bone wall.
Time Frame: At implant placement and after 16 weeks of healing.
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At implant placement and after 16 weeks of healing.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (ACTUAL)
June 1, 2011
Study Completion (ACTUAL)
June 14, 2011
Study Registration Dates
First Submitted
July 7, 2008
First Submitted That Met QC Criteria
July 7, 2008
First Posted (ESTIMATE)
July 8, 2008
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2023
Last Update Submitted That Met QC Criteria
February 3, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YA-OSS-0009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.