Dental ImplantationNCT00519571
Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory
A study testing ImplantLock device in people with Dental Implantation, run by Innovative Implant Solutions at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation
- What is being tested?
- ImplantLock device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical center
Jerusalem
Hanna Levy, Dr., 972-4-638-8837, hanna@qsitemed.com
About this study
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.
Read the 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.
- Conditions
- Dental Implantation
- Being tested
- ImplantLock device
- Keywords
- Dental Implantation, Endosseous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantLock deviceDevice
dental implant
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: ImplantLock device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device
Measured: 12 months
Secondary outcomes (2)
Determine endosseous implant stability while using ImplantLock Device
Measured: 12 months
Determine the ability to immediately apply continuous functional loading on endosseous implant while using ImplantLock Device
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startJul 2008
- Primary completionJun 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Implant Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Isaac Tayeb, Dr., Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519571
- Sponsor's protocol ID
- IL-01
- Status last verified
- May 2008
- First submitted
- 20 Aug 2007
- Last updated
- 9 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Using ImplantLock Device - Dental Implant Accessory
- ClinicalTrials.gov ID
- NCT00519571
- Acronym / sponsor ID
- IL-01
- Conditions
- Dental Implantation
- Keywords
- Dental Implantation, Endosseous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Innovative Implant SolutionsIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 22 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: ImplantLock device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImplantLock devicedental implant | Device | 1 |
Primary outcome
Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device
Time frame: 12 months
2 secondary outcomes
Determine endosseous implant stability while using ImplantLock Device
Time frame: 12 months
Determine the ability to immediately apply continuous functional loading on endosseous implant while using ImplantLock Device
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2008.
Related trials for Dental Implantation
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
RecruitingObservational study
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
Dental Implants
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac Tayeb, Dr. principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ImplantLock device in people with Dental Implantation, run by Innovative Implant Solutions at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna Levy, Dr (972-4-638-8837, hanna@qsitemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2008.