Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional Teeth Attached 6-7 Weeks Later

Not Applicable

Completed

• Conditions: Jaw, Edentulous, Partially

• Registration Number: NCT00711113
• Lead Sponsor: Dentsply Sirona Implants and Consumables

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 maxilla in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-08
• Primary Completion: 2011-09
• Results First Submitted: 2013-08-22
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-09
• Last Update Submitted: 2014-01-09
• Results First Posted: 2014-02-07
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Provision of written informed consent
• 18 years of age and over
• Edentulous in the posterior maxilla, Kennedy classes I or 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.
• Sinus floor thickness of less than 5 mm, verified by periapical radiographs.
• 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Implant Survival Rate	At 5 year follow-up	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.
Implant Stability	At 1 year follow-up	Implant stability was evaluated using Resonance Frequency Analysis (RFA). The RFA value was automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100. The ISQ value indicates the level of stability. Low values (\<60) indicate low stability, medium values (60-70) indicate medium stability and high values (\>70) indicate high stability.
Marginal Bone Adaptation	At baseline (loading) and at 5 year follow-up	Marginal bone adaptation was 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 were compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.

Trial Locations

Locations (3)

University of Iowa, College of Dentistry, Dow's Institute for Dental Research; 🇺🇸 Iowa City, Iowa, United States

UTHSCSA; 🇺🇸 San Antonio, Texas, United States

Universitetsklinik Mainz, Klinik fur ZMK; 🇩🇪 Mainz, Germany