Status and phase
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About
The current prospective clinical study's aim is to determine ABT's ICE implant survival rate, crestal interproximal bone resorption during 24 months post implant insertion and to assimilate the drilling sequence during the clinical use of ICE implants.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Immediate loaded implants.
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.
Primary purpose
Allocation
Interventional model
Masking
35 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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