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Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later

Primary Purpose

Jaw, Edentulous, Partially

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

OsseoSpeed™

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring Jaw, Edentulous, Partially (posterior mandible)

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
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

Exclusion Criteria:

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

Sites / Locations

The Ohio State University, College of Dentistry
University of Washington, Dept. of Restorative Dentistry
Georg-August-Universität, Göttingen, Abt. Mund-, Keifer-, und Gesicthschirurgie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00711425

First Posted

July 7, 2008

Last Updated

August 22, 2013

Sponsor

Dentsply Sirona Implants and Consumables

1. Study Identification

Unique Protocol Identification Number

NCT00711425

Brief Title

Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later

Official Title

An Open, Prospective Study to Evaluate Implant Stability, Marginal Bone Adaptation and the Survival Rate of Astra Tech Dental Implant System, Fixture Osseospeed™, in Patients With Tooth Loss in the Posterior Mandible in an Early Loading Protocol.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dentsply Sirona Implants and Consumables

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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 (posterior mandible)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

OsseoSpeed™

Intervention Description

OsseoSpeed™, all dimensions

Primary Outcome Measure Information:

Title

Implant Survival Rate

Description

Time Frame

At 5 year follow-up

Title

Implant Stability

Description

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.

Time Frame

At 1 year follow-up

Title

Marginal Bone Adaptation

Description

Time Frame

At 5 year follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of written informed consent 18 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edwin A McGlumphy, D.D.S.

Organizational Affiliation

The Ohio State University, College of Dentistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ohio State University, College of Dentistry

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210-1241

Country

United States

Facility Name

University of Washington, Dept. of Restorative Dentistry

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Facility Name

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

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

22111584

Citation

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.

Results Reference

result

Learn more about this trial

Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later

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