Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading

Dentsply Sirona Implants and Consumables19 enrolled

Overview

The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Jaw, Edentulous, Partially

Interventions

Astra Tech Fixture STDEVICE

Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 - 75 * Unilateral or bilateral edentulism in the posterior maxilla, last tooth should be the canine or the first bicuspid * Willing to give informed consent Exclusion Criteria: * Bone height \< 5 mm, in the planned implant area * Bone width \< 5 mm, in the planned implant area * Previous bone augmentation procedure in the planned implant area * Previous failures of endosseous implants * Untreated caries and/or periodontal disease of residual dentition * History or presence of any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration * Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration * Current alcohol or drug abuse * Unable or unwilling to return for follow-up visits for 3 years

Locations (2)

Dept. of Periodontology, New York Dept of Veterans Affairs Medical Center

New York, New York, United States

Dept. of Prosthodontics, New York Dept of Veterans Affairs Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Implant Survival Rate

An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meier method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.

Time frame: At follow-up visit: 6 months after implants have been loaded

Implant Survival Rate

An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.

Time frame: At follow-up visit: 1 year after implants have been loaded

Implant Survival Rate

An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.

Time frame: At follow-up visit: 2 years after implants have been loaded

Implant Survival Rate

An implant that has failed to osseointegrate, lost its osseointegration or fractured will be considered a failure effective from the date of removal. Implant Survival Rate will be calculated using the Kaplan-Meyer method based on the number of placed implants. Patients who discontinued the study after the last implant failure do not affect the cumulative survival rate.

Time frame: At follow-up visit: 3 years after implants have been loaded

Secondary Outcomes

Data from ClinicalTrials.gov

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