Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Survival and Success of MIS C1 Implants- a Field Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01707108
First received: October 11, 2012
Last updated: August 6, 2014
Last verified: August 2014
  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 Phase
Failure of Osseointegration of Dental Implant
Device: Dental Implant (MIS Technologies)
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study 1 and 3 year implant bone level changes of C1 implants [ Time Frame: 1 and 3 years post implantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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, PA 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707108

Contacts
Contact: Jacob Horwitz, DMD 972-4-854-2983 j_horwitz@rambam.health.gov.il
Contact: Liron Eliezer 972-4-854-2983 l_eliezer@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Contact: Jacob Horwitz, DMD    972-4-854-2983      
Principal Investigator: Jacob Horwitz, DMD         
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Jacob Horwitz, DMD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01707108     History of Changes
Other Study ID Numbers: 0113-12-RMB CTIL
Study First Received: October 11, 2012
Last Updated: August 6, 2014
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on November 25, 2014