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Survival and Success of MIS C1 Implants- a Field Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707108
First Posted: October 16, 2012
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rambam Health Care Campus
  Purpose

The aim of the present study is to evaluate the 1-year and 3-year survival and success of MIS® C1 implants with a length of 10-15mm.

Specific Aims

  1. To study 1-year and 3-year implant survival rate C1 implants
  2. To study 1-year and 3-year implant bone level changes of C1 implants

Condition Intervention
Failure of Osseointegration of Dental Implant Device: Dental Implant (MIS Technologies)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Survival and Success of MIS C1 Implants- a Field Study

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • To study 1 and 3 year implant survival rate C1 implants [ Time Frame: 1 and 3 years post implantation ]

Secondary Outcome Measures:
  • To study 1 and 3 year implant bone level changes of C1 implants [ Time Frame: 1 and 3 years post implantation ]

Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dental Implants
Rehabilitation of missing teeth with Dental Implant (MIS Technologies)
Device: Dental Implant (MIS Technologies)
MIS Technologies Ltd. C1 Dental implants

Detailed Description:

10 implants will be allocated to each of the twelve dentists, for a total of 120 implants. One test implant per patient will be allowed into the study for a total of 120 patients.

The following data will be collected for each patient/implant:

  1. Patient data including birthdate, health, surgery date.
  2. Implant length, diameter
  3. Insertion torque
  4. Periapical radiographs (at insertion, and twelve months post surgery).
  5. Post operative complications and adverse events.
  6. Periodontal data around Ramfjord teeth (16, 21, 24, 36, 41, 44) : Plaque index, Gingival Index, Probing depth in six sites and Bleeding on probing in six sites, at baseline and twelve months post surgery.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 18-75.
  2. Patient expresses his wish to restore the missing tooth/teeth with implant therapy.
  3. Partial edentulism with available bone height for dental implants ≥ 10mm mm.

Exclusion Criteria:

  1. Contraindicating medical conditions such as uncontrolled diabetes, untreated malignancies, pregnancy, previous/current bisphosphonate therapy.
  2. Untreated periodontal disease, untreated caries, periapical pathology in contact with the location of the perspective implant.
  3. Major bone augmentation in conjunction with implant placement. Localised bone augmentation in conjunction with implant placement, of up to 3 mm on 1-2 aspects of the implant will be allowed.
  4. One stage immediate loading/restoration.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707108


Locations
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Jacob Horwitz, DMD Rambam Health Care Campus
  More Information

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01707108     History of Changes
Other Study ID Numbers: 0113-12-RMB CTIL
First Submitted: October 11, 2012
First Posted: October 16, 2012
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by Rambam Health Care Campus:
dental implants
bone loss