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Clinical Trials/NCT01960361
NCT01960361CompletedPhase 4

A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of ICE Implant System Over 24 Months, for Patients With Tooth Loss Requiring up to 4 Implants, in Staged Loading Protocol

Alpha - Bio Tec Ltd.1 site in 1 country35 target enrollmentStarted: January 1, 2015Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
35
Locations
1
Primary Endpoint
Cumulative Survival Rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.
  • •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.

Arms & Interventions

ICE dental implant

Experimental

Subjects implanted with ICE implant

Intervention: ICE dental implant (Device)

Outcomes

Primary Outcomes

Cumulative Survival Rate

Time Frame: 24 MONTHS

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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