NCT00710944

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 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

April 1, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month 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
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

May 22, 2014

Completed
Last Updated

July 11, 2014

Status Verified

June 1, 2014

Enrollment Period

3.2 years

First QC Date

July 7, 2008

Results QC Date

March 12, 2014

Last Update Submit

June 26, 2014

Conditions

Jaw, Edentulous, Partially

Keywords

Jaw, Edentulous, Partially (missing/extracted/avulsed teeth in the maxilla within zone 15(4)-25(13))

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months after implant placement

Study Arms (3)

Extraction Sockets

EXPERIMENTAL

Immediate loading in extraction sockets.

Device: ASTRA TECH Implant System, OsseoSpeed™

Healed Ridges

EXPERIMENTAL

Immediate loading in healed ridges.

Device: ASTRA TECH Implant System, OsseoSpeed™

Grafted Sites

EXPERIMENTAL

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

Device: ASTRA TECH Implant System, OsseoSpeed™

Interventions

ASTRA TECH Implant System, OsseoSpeed™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.

Extraction SocketsGrafted SitesHealed Ridges

Eligibility Criteria

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

You may qualify if:

  • Provision of written informed consent
  • 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

You may not qualify if:

  • Untreated rampant caries and uncontrolled periodontal disease
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

School of Dentistry

Chapel Hill, North Carolina, 27599-7450, United States

Location

Dental School Department Periodontology

Ghent, B-9000, Belgium

Location

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

Kiel, 241 05, Germany

Location

Universitat Internacional de Catalunya, Department de Odontología

Barcelona, 08190, Spain

Location

Related Publications (4)

  • 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.

    PMID: 21197501RESULT

  • 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.

    PMID: 21504481RESULT

  • 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.

    PMID: 22469026RESULT

  • 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.

    PMID: 24818212RESULT

MeSH Terms

Conditions

Jaw, Edentulous, PartiallyMouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth DiseasesTooth Diseases

Results Point of Contact

Title
Senior Manager Global Clinical Research
Organization
DENTSPLY Implants
clinicalresearchmolndal@dentsply.com
+46313763500

Study Officials

  • Lyndon Cooper, Prof, DDS, PhD

    School of Dentistry, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON 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

April 1, 2005

Primary Completion

June 1, 2008

Study Completion

November 1, 2012

Last Updated

July 11, 2014

Results First Posted

May 22, 2014

Record last verified: 2014-06

Locations

US(1)BE(1)ES(1)DE(1)