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Completed

NCT Number: NCT01707108

Survival and Success of MIS C1 Implants- a Field Study

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rambam Health Care Campus

Haifa, 31096, Israel

About this study

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:

  • Patient data including birthdate, health, surgery date.
  • Implant length, diameter
  • Insertion torque
  • Periapical radiographs (at insertion, and twelve months post surgery).
  • Post operative complications and adverse events.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindicating medical conditions such as uncontrolled diabetes, untreated malignancies, pregnancy, previous/current bisphosphonate therapy.
  • Untreated periodontal disease, untreated caries, periapical pathology in contact with the location of the perspective implant.
  • 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.
  • One stage immediate loading/restoration.

Treatment and study plan

Dental Implant (MIS Technologies)

Device

MIS Technologies Ltd. C1 Dental implants

Primary outcomes

  1. Survival Rate

    Time frame: 1 year post implantation

    1 year survival rate

Secondary outcomes

  1. 1 Year Implant Bone Level Changes

    Time frame: 1 year post implantation

    bone change in millimeters after 1 year

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2012
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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