Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate survival for ASTRA TECH Implant System, OsseoSpeed™ implants following immediate loading in extraction sockets versus immediate loading in healed ridges. Patients in need of single standing implants replacing teeth in the maxilla within zone 15-25 will be included and followed for 5 years. Primary objective is implant survival rate at 12 months.

Official Title
-----------------
An Open, Prospective, Controlled Study in the Maxilla to Evaluate Clinical Outcome of ASTRA TECH Implant System, OsseoSpeed™ Implants in Single Tooth Replacement Using an Immediate Loading Protocol in Extraction Sockets and Healed Ridges.

Conditions
-----------------
Jaw, Edentulous, Partially

Intervention / Treatment
-----------------
* Device: ASTRA TECH Implant System, OsseoSpeed™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent 18 years of age and over A minimum of 20 stable intra occlusal contacts after planned restoration In need of single standing implants replacing missing / extracted / avulsed teeth in the maxilla within zone 15 to 25 Exclusion Criteria: Untreated rampant caries and uncontrolled periodontal disease Use of smoking tobacco at time of inclusion History of pre-surgical bone augmentation, within 4 months, in the planned implant area History of extraction without augmentation, within 3 months in the planned implant area Absence of opposing dentition Absence of adjacent (mesial and/or distal) natural tooth Uncontrolled diabetes Known pregnancy at time of inclusion Present alcohol or drug abuse 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 Unable or unwilling to return for follow-up visits for a period of 5 years Unrealistic esthetical demands Unlikely to be able to comply with study procedures according to Investigators judgment Already included in this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extraction Sockets<br>Immediate loading in extraction sockets. | Device: ASTRA TECH Implant System, OsseoSpeed™<br>* ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.<br>|
| Experimental: Healed Ridges<br>Immediate loading in healed ridges. | Device: ASTRA TECH Implant System, OsseoSpeed™<br>* ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.<br>|
| Experimental: Grafted Sites<br>Immediate loading of implants placed in grafted sites (four months healing after grafting). | Device: ASTRA TECH Implant System, OsseoSpeed™<br>* ASTRA TECH Implant System, OsseoSpeed™: Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival | 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. | 12 months after implant placement | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Jaw, Edentulous, Partially (missing/extracted/avulsed teeth in the maxilla within zone 15(4)-25(13))