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

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
OsseoSpeed™
OsseoSpeed™
Sponsored by
Dentsply Sirona Implants and Consumables
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring Replacement of non-restorable single tooth/teeth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Studio Odontoiatrico
  • Department of Periodontics, Faculty of Odontology, Universidad Complutense de Madrid
  • Department of Periodontology, School of Dental Medicine, University of Berne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Clinical measure of the thickness of the facial bone wall.

Secondary Outcome Measures

Full Information

First Posted
July 7, 2008
Last Updated
February 3, 2023
Sponsor
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT00711282
Brief Title
Study of Bone Preservation When OsseoSpeed™ Implants Are Placed Immediately Following Tooth Extraction
Official Title
A Prospective, Randomized, Controlled Study to Evaluate Buccal Bone Preservation Using Fixture MicroThread™ OsseoSpeed™ Placed in Fresh Extraction Sockets the Maxilla.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 14, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dentsply Sirona Implants and Consumables

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
Keywords
Replacement of non-restorable single tooth/teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
OsseoSpeed™
Intervention Description
OsseoSpeed™ MicroThread™, diameters of 3.5 and 4.0 mm.
Intervention Type
Device
Intervention Name(s)
OsseoSpeed™
Intervention Description
OsseoSpeed™ MicroThread™, diameters of 4.5 and 5.0 mm.
Primary Outcome Measure Information:
Title
Clinical measure of the thickness of the facial bone wall.
Time Frame
At implant placement and after 16 weeks of healing.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Studio Odontoiatrico
City
Padova
ZIP/Postal Code
351 25
Country
Italy
Facility Name
Department of Periodontics, Faculty of Odontology, Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Department of Periodontology, School of Dental Medicine, University of Berne
City
Berne
ZIP/Postal Code
CH-3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20070745
Citation
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.
Results Reference
result
PubMed Identifier
20070744
Citation
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.
Results Reference
result
PubMed Identifier
19922492
Citation
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.
Results Reference
result
PubMed Identifier
19912273
Citation
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.
Results Reference
result
PubMed Identifier
23431960
Citation
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.
Results Reference
result
PubMed Identifier
24298982
Citation
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.
Results Reference
result

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

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