Survival and Success of MIS C1 Implants- a Field Study

Study Overview
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Brief Summary
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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 To study 1-year and 3-year implant survival rate C1 implants To study 1-year and 3-year implant bone level changes of C1 implants

Detailed Description
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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.

Official Title
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Survival and Success of MIS C1 Implants- a Field Study

Conditions
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Failure of Osseointegration of Dental Implant

Intervention / Treatment
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* Device: Dental Implant (MIS Technologies)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dental Implants<br>Rehabilitation of missing teeth with Dental Implant (MIS Technologies) | Device: Dental Implant (MIS Technologies)<br>* MIS Technologies Ltd. C1 Dental implants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate | 1 year survival rate | 1 year post implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 Year Implant Bone Level Changes | bone change in millimeters after 1 year | 1 year post implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implants, bone loss