Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00519571

Enrollment

Registered

2007-08-22

Start date

2008-07-31

Completion date

2009-07-31

Last updated

2008-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implantation

Keywords

Dental Implantation, Endosseous

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.

Interventions

DEVICEImplantLock device

dental implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device	12 months

Secondary

Measure	Time frame
Determine endosseous implant stability while using ImplantLock Device	12 months
Determine the ability to immediately apply continuous functional loading on endosseous implant while using ImplantLock Device	12 months

Countries

Israel

Contacts

Primary ContactHanna Levy, Dr

hanna@qsitemed.com972-4-638-8837

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026