Clinical trial NCT00519571: Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory
Official title: Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implantation
Keywords: Dental Implantation, Endosseous
Lead sponsor: Innovative Implant Solutions
Sponsor class: INDUSTRY
First posted: 2007-08-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the safety and effectiveness of the ImplantLock device and its contribution to 8.0 mm long root-form endosseous implants stability under immediately applied continuous functional loading.

Detailed description: Primary Endpoints

* Serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device will be documented in Serious Adverse Event Form.
* Adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device will be documented in Adverse Event Form.

Secondary Endpoints

* Determine 8.0 mm long endosseous implant stability while using ImplantLock Device. Stability will be routinely assessed.
* Determine the ability to immediately apply continuous functional loading on 8.0 mm long endosseous implant while using ImplantLock Device. The ability to immediately apply continuous functional loading will be routinely assessed.

Eligibility criteria: Inclusion Criteria:

* Male/Female age 18 and up.
* Subject is schedule for endosseous implantation treatment.
* Subject able to comprehend and give informed consent for participation in this study.
* Signed informed consent form.

Exclusion Criteria:

* Subjects suffering from a disease that might disturb bone regeneration healing process e.g. osteoporosis, anemia, etc.
* Acute infection requiring intravenous antibiotics at the time of screening.
* Bleeding disorders.
* Uncontrolled diabetes mellitus
* HIV positive or any other immunosuppressive disorder.
* Renal failure (Serum creatinine \>2.0 mg/dl).
* Subject with allergies to metal alloys.
* Coagulation disorder.
* Infection / abscess / pains in treatment target area.
* Pregnant or nursing woman.
* Resent history of alcohol or drug abuse (within the last 2 years).
* Subject is smoking.
* Subject is suffering extreme general weakness.
* Subject objects to the study protocol.
* Known cognitive or psychiatric disorder
* Concurrent participation in any other clinical study.
* Physician objection.

Primary outcomes:
measure: Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device
timeFrame: 12 months
Secondary outcomes:
measure: Determine endosseous implant stability while using ImplantLock Device
timeFrame: 12 months
measure: Determine the ability to immediately apply continuous functional loading on endosseous implant while using ImplantLock Device
timeFrame: 12 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical center
Study officials:
affiliation: Hadassah Medical Organization
name: Isaac Tayeb, Dr.
role: PRINCIPAL_INVESTIGATOR
References: