Study on OsseoSpeed™ Implants in Patients Missing 2-5 Teeth in the Posterior Lower Jaw, Restored With Permanent Teeth Attached 6-7 Weeks Later

The purpose of the study is to evaluate Astra Tech Dental Implant System, Fixture Osseospeed™, in patients with tooth loss in the posterior mandible in an early loading protocol. Primary objectives are implant stability, marginal bone adaptation and survival rate.

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Key information

Conditions

Jaw, Edentulous, Partially Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georg-August-Universität, Göttingen, Abt. Mund-, Keifer-, und Gesicthschirurgie, Göttingen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Provision of written informed consent
18 years of age and over
Edentulous in the posterior mandible, Kennedy class I or class II. Last natural tooth, or previously restored implant in function is canine or first bicuspid.
Deemed by the investigator as likely to present an initially stabile implant situation suitable for early loading

Exclusion criteria

Untreated caries and/or periodontal disease of residual dentition
History of edentulism in the area of implant placement of less than two months
Current need for pre-surgical bone or soft tissue augmentation in the planned implant area.
History of pre-surgical bone or soft tissue augmentation, within12 months, in the planned implant area.
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
Present alcohol or drug abuse
Unable or unwilling to return for follow-up visits for a period of 5 years
Current use of smoking tobacco
Pregnancy or lactation at the time of enrollment

Treatment and study plan

OsseoSpeed™

Device

OsseoSpeed™, all dimensions

Primary outcomes

Implant Survival Rate

Time frame: At 5 year follow-up

An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. The survival rate for individual implants will be analyzed at each visit. Cumulative implant survival rate will be calculated using Kaplan-Meier life-table estimation and reported as percentage of survived implants.
Implant Stability

Time frame: At 1 year follow-up

Implant stability will be evaluated using Resonance Frequency Analysis (RFA). The RFA value is automatically translated into an Implant Stability Quotient index (ISQ), which runs from 1 to 100.
Marginal Bone Adaptation

Time frame: At 5 year follow-up

Marginal bone adaptation will be expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. Bone adaptation in millimeters at follow-up visit will be compared to values obtained Baseline (loading). Positive value indicates bone gain and negative value bone loss.

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Official study title

An Open, Prospective Study to Evaluate Implant Stability, Marginal Bone Adaptation and the Survival Rate of Astra Tech Dental Implant System, Fixture Osseospeed™, in Patients With Tooth Loss in the Posterior Mandible in an Early Loading Protocol.

Important dates

Study start: 2004
Primary completion: 2010
First posted: Jul 8, 2008
Registry last updated: Sep 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed