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Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ASTRA TECH Implant System, 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 Jaw, Edentulous, Partially (missing/extracted/avulsed teeth in the maxilla within zone 15(4)-25(13))

Eligibility Criteria

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

Inclusion Criteria:

  • Provision of written informed consent
  • 18 years of age and over
  • A minimum of 20 stable intra occlusal contacts after planned restoration
  • In need of single standing implants replacing missing / extracted / avulsed teeth in the maxilla within zone 15 to 25

Exclusion Criteria:

  • Untreated rampant caries and uncontrolled periodontal disease
  • Use of smoking tobacco at time of inclusion
  • History of pre-surgical bone augmentation, within 4 months, in the planned implant area
  • History of extraction without augmentation, within 3 months in the planned implant area
  • Absence of opposing dentition
  • Absence of adjacent (mesial and/or distal) natural tooth
  • Uncontrolled diabetes
  • Known pregnancy at time of inclusion
  • Present alcohol or drug abuse
  • Any 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
  • Unable or unwilling to return for follow-up visits for a period of 5 years
  • Unrealistic esthetical demands
  • Unlikely to be able to comply with study procedures according to Investigators judgment
  • Already included in this study

Sites / Locations

  • School of Dentistry
  • Dental School Department Periodontology
  • Department of Oromaxillofacial Surgery, Hospital of the Christian- Albrechts University at Kiel
  • Universitat Internacional de Catalunya, Department de Odontología

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Extraction Sockets

Healed Ridges

Grafted Sites

Arm Description

Immediate loading in extraction sockets.

Immediate loading in healed ridges.

Immediate loading of implants placed in grafted sites (four months healing after grafting).

Outcomes

Primary Outcome Measures

Implant Survival
An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.

Secondary Outcome Measures

Full Information

First Posted
July 7, 2008
Last Updated
June 26, 2014
Sponsor
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT00710944
Brief Title
Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges
Official Title
An Open, Prospective, Controlled Study in the Maxilla to Evaluate Clinical Outcome of ASTRA TECH Implant System, OsseoSpeed™ Implants in Single Tooth Replacement Using an Immediate Loading Protocol in Extraction Sockets and Healed Ridges.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
November 2012 (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 survival for ASTRA TECH Implant System, OsseoSpeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges. Patients in need of single standing implants replacing teeth in the maxilla within zone 15-25 will be included and followed for 5 years. Primary objective is implant survival rate at 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
Keywords
Jaw, Edentulous, Partially (missing/extracted/avulsed teeth in the maxilla within zone 15(4)-25(13))

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Extraction Sockets
Arm Type
Experimental
Arm Description
Immediate loading in extraction sockets.
Arm Title
Healed Ridges
Arm Type
Experimental
Arm Description
Immediate loading in healed ridges.
Arm Title
Grafted Sites
Arm Type
Experimental
Arm Description
Immediate loading of implants placed in grafted sites (four months healing after grafting).
Intervention Type
Device
Intervention Name(s)
ASTRA TECH Implant System, OsseoSpeed™
Intervention Description
ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.
Primary Outcome Measure Information:
Title
Implant Survival
Description
An implant that has failed to osseointegrate, lost its osseointegration or fractured was considered a failure effective from the date of removal. The survival rate for individual implants was analyzed at each visit. Cumulative implant survival rate was calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
Time Frame
12 months after implant placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of written informed consent 18 years of age and over A minimum of 20 stable intra occlusal contacts after planned restoration In need of single standing implants replacing missing / extracted / avulsed teeth in the maxilla within zone 15 to 25 Exclusion Criteria: Untreated rampant caries and uncontrolled periodontal disease Use of smoking tobacco at time of inclusion History of pre-surgical bone augmentation, within 4 months, in the planned implant area History of extraction without augmentation, within 3 months in the planned implant area Absence of opposing dentition Absence of adjacent (mesial and/or distal) natural tooth Uncontrolled diabetes Known pregnancy at time of inclusion Present alcohol or drug abuse Any 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 Unable or unwilling to return for follow-up visits for a period of 5 years Unrealistic esthetical demands Unlikely to be able to comply with study procedures according to Investigators judgment Already included in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Cooper, Prof, DDS, PhD
Organizational Affiliation
School of Dentistry, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7450
Country
United States
Facility Name
Dental School Department Periodontology
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Department of Oromaxillofacial Surgery, Hospital of the Christian- Albrechts University at Kiel
City
Kiel
ZIP/Postal Code
241 05
Country
Germany
Facility Name
Universitat Internacional de Catalunya, Department de Odontología
City
Barcelona
ZIP/Postal Code
08190
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21197501
Citation
Cooper LF, Raes F, Reside GJ, Garriga JS, Tarrida LG, Wiltfang J, Kern M, de Bruyn H. Comparison of radiographic and clinical outcomes following immediate provisionalization of single-tooth dental implants placed in healed alveolar ridges and extraction sockets. Int J Oral Maxillofac Implants. 2010 Nov-Dec;25(6):1222-32.
Results Reference
result
PubMed Identifier
21504481
Citation
Raes F, Cooper LF, Tarrida LG, Vandromme H, De Bruyn H. A case-control study assessing oral-health-related quality of life after immediately loaded single implants in healed alveolar ridges or extraction sockets. Clin Oral Implants Res. 2012 May;23(5):602-8. doi: 10.1111/j.1600-0501.2011.02178.x. Epub 2011 Apr 19.
Results Reference
result
PubMed Identifier
22469026
Citation
De Bruyn H, Raes F, Cooper LF, Reside G, Garriga JS, Tarrida LG, Wiltfang J, Kern M. Three-years clinical outcome of immediate provisionalization of single Osseospeed() implants in extraction sockets and healed ridges. Clin Oral Implants Res. 2013 Feb;24(2):217-23. doi: 10.1111/j.1600-0501.2012.02449.x. Epub 2012 Apr 2.
Results Reference
result
PubMed Identifier
24818212
Citation
Cooper LF, Reside GJ, Raes F, Garriga JS, Tarrida LG, Wiltfang J, Kern M, De Bruyn H. Immediate provisionalization of dental implants placed in healed alveolar ridges and extraction sockets: a 5-year prospective evaluation. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):709-17. doi: 10.11607/jomi.3617.
Results Reference
result

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Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges

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