NCT00711425

Brief Summary

The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior mandible in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
2 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

February 1, 2004

Completed
4.4 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
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

September 26, 2011

Completed
Last Updated

September 9, 2013

Status Verified

August 1, 2013

Enrollment Period

5.9 years

First QC Date

July 7, 2008

Results QC Date

June 7, 2011

Last Update Submit

August 22, 2013

Conditions

Jaw, Edentulous, Partially

Keywords

Jaw, Edentulous, Partially (posterior mandible)

Outcome Measures

Primary Outcomes (3)

  • Implant Survival Rate

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

    At 5 year follow-up

  • Implant Stability

    Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.

    At 1 year follow-up

  • Marginal Bone Adaptation

    Marginal bone adaptation will be expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.

    At 5 year follow-up

Study Arms (1)

A

EXPERIMENTAL
Device: OsseoSpeed™

Interventions

OsseoSpeed™DEVICE

OsseoSpeed™, all dimensions

A

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
  • Edentulous in the posterior mandible, Kennedy class I or class II. Last natural tooth, or previously restored implant in function is canine or first bicuspid.
  • Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading

You may not qualify if:

  • Untreated caries and/or periodontal disease of residual dentition
  • History of edentulism in the area of implant placement of less than two months
  • Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
  • History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
  • 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
  • Present alcohol or drug abuse
  • Unable or unwilling to return for follow-up visits for a period of 5 years
  • Current use of smoking tobacco
  • Pregnancy or lactation at the time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Ohio State University, College of Dentistry

Columbus, Ohio, 43210-1241, United States

Location

University of Washington, Dept. of Restorative Dentistry

Seattle, Washington, 98195, United States

Location

Georg-August-Universität, Göttingen, Abt. Mund-, Keifer-, und Gesicthschirurgie

Göttingen, 37075, Germany

Location

Related Publications (1)

  • Schliephake H, Rodiger M, Phillips K, McGlumphy EA, Chacon GE, Larsen P. Early loading of surface modified implants in the posterior mandible - 5 year results of an open prospective non-controlled study. J Clin Periodontol. 2012 Feb;39(2):188-95. doi: 10.1111/j.1600-051X.2011.01816.x. Epub 2011 Nov 23.

    PMID: 22111584RESULT

MeSH Terms

Conditions

Jaw, Edentulous, PartiallyMouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth DiseasesTooth Diseases

Results Point of Contact

Title
Manager Global Clinical Operations
Organization
DENTSPLY Implants
+46313763500

Study Officials

  • Edwin A McGlumphy, D.D.S.

    The Ohio State University, College of Dentistry

    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
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 8, 2008

Study Start

February 1, 2004

Primary Completion

January 1, 2010

Last Updated

September 9, 2013

Results First Posted

September 26, 2011

Record last verified: 2013-08

Locations

DE(1)US(2)