NCT00519571

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 9, 2008

Status Verified

May 1, 2008

Enrollment Period

11 months

First QC Date

August 20, 2007

Last Update Submit

May 8, 2008

Conditions

Dental Implantation

Keywords

Dental Implantation, Endosseous

Outcome Measures

Primary Outcomes (1)

  • Adverse events and serious adverse events occurrence rate (during implantation procedure or following implantation) related to the ImplantLock device

    12 months

Secondary Outcomes (2)

  • 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

Study Arms (1)

1

EXPERIMENTAL
Device: ImplantLock device

Interventions

ImplantLock deviceDEVICE

dental implant

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical center

Jerusalem, Israel

Location

Study Officials

  • Isaac Tayeb, Dr.

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Levy, Dr

CONTACT

972-4-638-8837hanna@qsitemed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 22, 2007

Study Start

July 1, 2008

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

May 9, 2008

Record last verified: 2008-05

Locations

IL(1)