A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of SPI Implant

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.
• Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
• Degenerative diseases.
• Osteoradionecrosis.
• Renal failure.
• Organ transplant recipients.
• HIV positive.
• Malignant diseases.
• Diseases that compromise the immune system.
• Unbalanced diabetes mellitus. (HbA1c above 6.5)
• Psychotic diseases.
• Hypersensitivity to one of the components of the implant in general and titanium in particular.
• Women who are pregnant or lactating.
• Lack of patient cooperation.
• Uncontrolled endocrine diseases.
• Any systemic condition that is unbalanced and therefore precludes surgical procedures.
• Parafunctional habits.- e.g Bruxism.
• Temporomandibular joint disease.
• Various pathologies of the oral mucosa for example: Benign mucous pemphigoid, desquamative ginigivitis, erosive lichen planus ,malignancy of oral cavity, bolus erosive diseases of the oral mucosa.
• Flapless procedures.

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