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

NCT ID: NCT00710944

Last Updated: 2014-07-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Jaw, Edentulous, Partially

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Extraction Sockets

Immediate loading in extraction sockets.

Group Type EXPERIMENTAL

ASTRA TECH Implant System, OsseoSpeed™

Intervention Type DEVICE

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.

Healed Ridges

Immediate loading in healed ridges.

Group Type EXPERIMENTAL

ASTRA TECH Implant System, OsseoSpeed™

Intervention Type DEVICE

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.

Grafted Sites

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

Group Type EXPERIMENTAL

ASTRA TECH Implant System, OsseoSpeed™

Intervention Type DEVICE

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.

Interventions

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ASTRA TECH Implant System, OsseoSpeed™

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lyndon Cooper, Prof, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Dentistry, Chapel Hill

Locations

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School of Dentistry

Chapel Hill, North Carolina, United States

Site Status

Dental School Department Periodontology

Ghent, , Belgium

Site Status

Department of Oromaxillofacial Surgery, Hospital of the Christian- Albrechts University at Kiel

Kiel, , Germany

Site Status

Universitat Internacional de Catalunya, Department de Odontología

Barcelona, , Spain

Site Status

Countries

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United States Belgium Germany Spain

References

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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.

Reference Type RESULT
PMID: 21197501 (View on PubMed)

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.

Reference Type RESULT
PMID: 21504481 (View on PubMed)

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.

Reference Type RESULT
PMID: 22469026 (View on PubMed)

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.

Reference Type RESULT
PMID: 24818212 (View on PubMed)

Other Identifiers

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YA-OSS-0006

Identifier Type: -

Identifier Source: org_study_id

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