NCT01707108CompletedNot Applicable
Survival and Success of MIS C1 Implants- a Field Study
Rambam Health Care Campus1 site in 1 country120 target enrollmentStarted: January 28, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Survival Rate
Study Overview
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
- 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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age between 18-
- •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.
Arms & Interventions
Dental Implants
Experimental
Rehabilitation of missing teeth with Dental Implant (MIS Technologies)
Intervention: Dental Implant (MIS Technologies) (Device)
Outcomes
Primary Outcomes
Survival Rate
Time Frame: 1 year post implantation
1 year survival rate
Secondary Outcomes
- 1 Year Implant Bone Level Changes(1 year post implantation)
Investigators
Study Sites (1)
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