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

Jaw, Edentulous, Partially Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711425
• Other study ID #: YA-OSS-0002
• Status: Completed
• Phase: N/A
• First received: July 7, 2008
• Last updated: August 22, 2013
• Start date: February 2004

Study information

• Verified date: August 2013
• Source: Dentsply Implants
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially
• Mouth, Edentulous

Intervention

Device:
• OsseoSpeed™
OsseoSpeed™, all dimensions

Locations

Country	Name	City	State
Germany	Georg-August-Universität, Göttingen, Abt. Mund-, Keifer-, und Gesicthschirurgie	Göttingen
United States	The Ohio State University, College of Dentistry	Columbus	Ohio
United States	University of Washington, Dept. of Restorative Dentistry	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Implants

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (1)

Schliephake H, Rödiger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No