NCT00711282

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 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2011

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

5.5 years

First QC Date

July 7, 2008

Last Update Submit

February 3, 2023

Conditions

Jaw, Edentulous, Partially

Keywords

Replacement of non-restorable single tooth/teeth

Outcome Measures

Primary Outcomes (1)

  • Clinical measure of the thickness of the facial bone wall.

    At implant placement and after 16 weeks of healing.

Study Arms (2)

A

EXPERIMENTAL
Device: OsseoSpeed™

B

EXPERIMENTAL
Device: OsseoSpeed™

Interventions

OsseoSpeed™DEVICE

OsseoSpeed™ MicroThread™, diameters of 3.5 and 4.0 mm.

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of written informed consent
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Studio Odontoiatrico

Padua, 351 25, Italy

Location

Department of Periodontics, Faculty of Odontology, Universidad Complutense de Madrid

Madrid, 28040, Spain

Location

Department of Periodontology, School of Dental Medicine, University of Berne

Bern, CH-3010, Switzerland

Location

Related Publications (6)

  • 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.

    PMID: 20070745RESULT

  • 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.

    PMID: 20070744RESULT

  • 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.

    PMID: 19922492RESULT

  • 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.

    PMID: 19912273RESULT

  • 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.

    PMID: 23431960RESULT

  • 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.

    PMID: 24298982RESULT

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 8, 2008

Study Start

December 1, 2005

Primary Completion

June 1, 2011

Study Completion

June 14, 2011

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

CH(1)IT(1)ES(1)