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

Jaw, Edentulous, Partially Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710944
• Other study ID #: YA-OSS-0006
• Status: Completed
• Phase: N/A
• First received: July 7, 2008
• Last updated: June 26, 2014
• Start date: April 2005
• Est. completion date: November 2012

Study information

• Verified date: June 2014
• Source: Dentsply Implants
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardBelgium: Institutional Review BoardGermany: Ethics CommissionSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: November 2012
• Est. primary completion date: June 2008
• 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

• 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially
• Mouth, Edentulous

Intervention

Device:
• ASTRA TECH Implant System, OsseoSpeed™
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.

Locations

Country	Name	City	State
Belgium	Dental School Department Periodontology	Ghent
Germany	Department of Oromaxillofacial Surgery, Hospital of the Christian- Albrechts University at Kiel	Kiel
Spain	Universitat Internacional de Catalunya, Department de Odontología	Barcelona
United States	School of Dentistry	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Implants

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Spain, 

References & Publications (4)

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 s — View 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. — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No