Study on OsseoSpeed™ Implants Replacing 2-5 Teeth in the Posterior Upper Jaw, Restored With Provisional 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 Maxilla in an Early Loading Protocol.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711113
• Other study ID #: YA-OSS-0001
• Status: Completed
• Phase: N/A
• First received: July 7, 2008
• Last updated: January 9, 2014
• Start date: December 2003

Study information

• Verified date: January 2014
• 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 maxilla in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. primary completion date: September 2011
• 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 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

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	Universitetsklinik Mainz, Klinik fur ZMK	Mainz
United States	University of Iowa, College of Dentistry, Dow's Institute for Dental Research	Iowa City	Iowa
United States	UTHSCSA	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Implants

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Survival Rate	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.	At 5 year follow-up	No
Primary	Implant Stability	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.	At 1 year follow-up	No
Primary	Marginal Bone Adaptation	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.	At baseline (loading) and at 5 year follow-up	No