Clinical trial NCT00710944: Study to Compare Survival for ASTRA TECH Implant System, OsseoSpeed™ Implants Following Immediate Loading in Extraction Sockets Versus Immediate Loading in Healed Ridges
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Keywords: Jaw, Edentulous, Partially (missing/extracted/avulsed teeth in the maxilla within zone 15(4)-25(13))
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Implant Survival
timeFrame: 12 months after implant placement
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: School of Dentistry
state: North Carolina
city: Ghent
country: Belgium
facility: Dental School Department Periodontology
city: Kiel
country: Germany
facility: Department of Oromaxillofacial Surgery, Hospital of the Christian- Albrechts University at Kiel
city: Barcelona
country: Spain
facility: Universitat Internacional de Catalunya, Department de Odontología
Study officials:
affiliation: School of Dentistry, Chapel Hill
name: Lyndon Cooper, Prof, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cooper LF, Raes F, Reside GJ, Garriga JS, Tarrida LG, Wiltfang J, Kern M, de Bruyn H. Comparison of radiographic and clinical outcomes following immediate provisionalization of single-tooth dental implants placed in healed alveolar ridges and extraction sockets. Int J Oral Maxillofac Implants. 2010 Nov-Dec;25(6):1222-32.
citation: Raes F, Cooper LF, Tarrida LG, Vandromme H, De Bruyn H. A case-control study assessing oral-health-related quality of life after immediately loaded single implants in healed alveolar ridges or extraction sockets. Clin Oral Implants Res. 2012 May;23(5):602-8. doi: 10.1111/j.1600-0501.2011.02178.x. Epub 2011 Apr 19.
citation: De Bruyn H, Raes F, Cooper LF, Reside G, Garriga JS, Tarrida LG, Wiltfang J, Kern M. Three-years clinical outcome of immediate provisionalization of single Osseospeed() implants in extraction sockets and healed ridges. Clin Oral Implants Res. 2013 Feb;24(2):217-23. doi: 10.1111/j.1600-0501.2012.02449.x. Epub 2012 Apr 2.
citation: Cooper LF, Reside GJ, Raes F, Garriga JS, Tarrida LG, Wiltfang J, Kern M, De Bruyn H. Immediate provisionalization of dental implants placed in healed alveolar ridges and extraction sockets: a 5-year prospective evaluation. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):709-17. doi: 10.11607/jomi.3617.