Back to resultsA Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of ICE Implant (ICE)
Primary Purpose
Implant Clinical Survival, Dental Implant Bone Loss
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
ICE dental implant
Sponsored by
About this trial
This is an interventional treatment trial for Implant Clinical Survival
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.
- 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.
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Sites / Locations
- Assaf Harofeh Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ICE dental implant
Arm Description
Subjects implanted with ICE implant
Outcomes
Primary Outcome Measures
Cumulative Survival Rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01960361
Brief Title
A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of ICE Implant
Acronym
ICE
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alpha - Bio Tec Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implant Clinical Survival, Dental Implant Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICE dental implant
Arm Type
Experimental
Arm Description
Subjects implanted with ICE implant
Intervention Type
Device
Intervention Name(s)
ICE dental implant
Intervention Description
ICE- Implant Classical Esthetic implant
Primary Outcome Measure Information:
Title
Cumulative Survival Rate
Time Frame
24 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
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.
-
Facility Information:
Facility Name
Assaf Harofeh Medical Center
City
Rishon leZion
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of ICE Implant
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