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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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Alpha - Bio Tec Ltd.
Sponsor:
Information provided by (Responsible Party):
Alpha - Bio Tec Ltd.
ClinicalTrials.gov Identifier:
NCT01960361
First received: October 9, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Dental Implant Survival Rate
Dental Implant Bone Loss
Device: ICE dental implant

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Alpha - Bio Tec Ltd.:

Primary Outcome Measures:
  • Cumulative Survival Rate [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICE dental implant Device: ICE dental implant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Immediate loaded implants.
  2. Treatment with anticoagulant drugs (INR under 1.8) or bisphosphonates.
  3. Treatment with anticonvulsants drugs.
  4. Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
  5. Patients with history of alcohol, narcotics or drug abuse.
  6. Patients under steroid therapy.
  7. 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.

  8. Metabolic bone disorders and/or bone augmentation.
  9. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
  10. Degenerative diseases.
  11. Osteoradionecrosis.
  12. Renal failure.
  13. Organ transplant recipients.
  14. HIV positive.
  15. Malignant diseases.
  16. Diseases that compromise the immune system.
  17. Unbalanced diabetes mellitus. (HbA1c above 6.5)
  18. Psychotic diseases.
  19. Hypersensitivity to one of the components of the implant in general and titanium in particular.
  20. Women who are pregnant or lactating.
  21. Lack of patient cooperation.
  22. Uncontrolled endocrine diseases.
  23. Any systemic condition that is unbalanced and therefore precludes surgical procedures.
  24. Parafunctional habits.- e.g Bruxism.
  25. Temporomandibular joint disease.
  26. 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.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960361

Locations
Israel
Ziv medical center Not yet recruiting
Zefat, Israel
Assaf Harofeh Medical Center Not yet recruiting
Zerifin, Israel, 70300
Sponsors and Collaborators
Alpha - Bio Tec Ltd.
  More Information

No publications provided

Responsible Party: Alpha - Bio Tec Ltd.
ClinicalTrials.gov Identifier: NCT01960361     History of Changes
Other Study ID Numbers: ICE_001
Study First Received: October 9, 2013
Last Updated: October 9, 2013
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on November 27, 2014