An Open, Prospective, Multi-center Study to Evaluate Bone Loss, the Survival Rate of SPI Implant System and Implant Stability Over a 24 Months, in Patients With Tooth Loss Requiring up to 4 Implants, in Staged Loading Protocol.

Alpha - Bio Tec Ltd.3 sites in 1 country88 target enrollmentNovember 2014

ConditionsImplant Clinical Survival Dental Implant Bone Loss

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Implant Clinical Survival
Sponsor: Alpha - Bio Tec Ltd.
Enrollment: 88
Locations: 3
Primary Endpoint: Cumulative Survival Rate
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The current prospective clinical study's aim is to determine ABT's SPI implant survival rate, crestal interproximal bone resorption during 24 months post implant insertion and to assimilate the drilling sequence during the clinical use of SPI implants.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

June 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Alpha - Bio Tec Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and women over the age of 18 years who need implantation of 1-4 implants.
•Patients who are able to understand the requirements of the study, and are willing and able to comply with its instructions and schedules.
•Patients who had provided written informed consent to participate in the study prior to any study procedure.
•Patients in general good health in the opinion of the principal investigator as determined by medical history and oral examination.

Exclusion Criteria

•Immediate loaded implants.
•Patient requiring bone augmentation
•Treatment with anticoagulant drugs (INR under 1.8) or bisphosphonates.
•Treatment with anticonvulsants drugs.
•Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
•Patients with history of alcohol, narcotics or drug abuse.
•Patients under steroid therapy.
•Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years.
•Patients through at anytime received radiotherapy to the head and neck region will be excluded anyway.
•Metabolic bone disorders and/or bone augmentation.