N/A N=132 Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT00710944 ↗

Enrolled (actual)

132

Serious AEs

3.0%

Results posted

May 2014

Primary outcome: Primary: Implant Survival — 94.55; 98.28; 94.73 percentage of implants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ASTRA TECH Implant System, OsseoSpeed™ (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dentsply Sirona Implants and Consumables
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Implant Survival	94.55; 98.28; 94.73	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00710944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.