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

Not Applicable

Completed

• Conditions: Jaw, Edentulous, Partially
• Interventions: Device: ASTRA TECH Implant System, OsseoSpeed™

• Registration Number: NCT00710944
• Lead Sponsor: Dentsply Sirona Implants and Consumables

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2008-06
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-08
• Study Completion: 2012-11
• Results First Submitted: 2014-03-12
• Results First Submitted QC: 2014-04-28
• Results First Posted: 2014-05-22
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-26
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extraction Sockets	ASTRA TECH Implant System, OsseoSpeed™	Immediate loading in extraction sockets.
Healed Ridges	ASTRA TECH Implant System, OsseoSpeed™	Immediate loading in healed ridges.
Grafted Sites	ASTRA TECH Implant System, OsseoSpeed™	Immediate loading of implants placed in grafted sites (four months healing after grafting).

Primary Outcome Measures

Name	Time	Method
Implant Survival	12 months after implant placement	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.

Trial Locations

Locations (4)

Dental School Department Periodontology; 🇧🇪 Ghent, Belgium

School of Dentistry; 🇺🇸 Chapel Hill, North Carolina, United States

Department of Oromaxillofacial Surgery, Hospital of the Christian- Albrechts University at Kiel; 🇩🇪 Kiel, Germany

Universitat Internacional de Catalunya, Department de Odontología; 🇪🇸 Barcelona, Spain