CompletedNCT00711282Updated Feb 6, 2023

Study of Bone Preservation When OsseoSpeed™ Implants Are Placed Immediately Following Tooth Extraction

An interventional study of OsseoSpeed™ and OsseoSpeed™ in Jaw, Edentulous, Partially, sponsored by Dentsply Sirona Implants and Consumables. Completed at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-06.

Sponsored by Dentsply Sirona Implants and Consumables · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 104
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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.

Conditions studied

Jaw, Edentulous, Partially

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Keywords

Replacement of non-restorable single tooth/teeth

In context

Jaw, Edentulous

171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.

This study's enrollment of 104 is above the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

Dentsply Sirona Implants and Consumables is the lead sponsor of 35 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 104 participants (actual)

Study arms

Experimental
A
Device: OsseoSpeed™
Experimental
B
Device: OsseoSpeed™

Interventions

DeviceOsseoSpeed™
OsseoSpeed™ MicroThread™, diameters of 3.5 and 4.0 mm.
DeviceOsseoSpeed™
OsseoSpeed™ MicroThread™, diameters of 4.5 and 5.0 mm.

What researchers measure

Primary outcomes

Clinical measure of the thickness of the facial bone wall.
Time frame: At implant placement and after 16 weeks of healing.

Study locations

3 sites

Studio Odontoiatrico
Padova, 351 25, Italy
Department of Periodontics, Faculty of Odontology, Universidad Complutense de Madrid
Madrid, 28040, Spain
Department of Periodontology, School of Dental Medicine, University of Berne
Berne, CH-3010, Switzerland

References and documents

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. PubMed 20070745 ↗
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. PubMed 20070744 ↗
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. PubMed 19922492 ↗
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. PubMed 19912273 ↗
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. PubMed 23431960 ↗
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. PubMed 24298982 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00711282
Lead sponsor: Dentsply Sirona Implants and Consumables
Responsible party: Sponsor
First posted: Jul 8, 2008
Start date: Dec 2005
Primary completion: Jun 2011
Completion: Jun 14, 2011
Last update: Feb 6, 2023

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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