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Survival and Success of MIS C1 Implants- a Field Study

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ClinicalTrials.gov Identifier: NCT01707108
Recruitment Status : Active, not recruiting
First Posted : October 16, 2012
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

Brief Summary:

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 or disease Intervention/treatment Phase
Failure of Osseointegration of Dental Implant Device: Dental Implant (MIS Technologies) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Survival and Success of MIS C1 Implants- a Field Study
Study Start Date : February 2013
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Dental Implants
Rehabilitation of missing teeth with Dental Implant (MIS Technologies)
Device: Dental Implant (MIS Technologies)
MIS Technologies Ltd. C1 Dental implants




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

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

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

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