Survival and Success of MIS C1 Implants- a Field Study
Phase: NA
Conditions: Failure of Osseointegration of Dental Implant
Sponsor: Rambam Health Care Campus

C1 Implant Study 
January 24, 2013 
 
Protocol Version 3. January 24, 2013. 
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Survival and success of MIS C1 implants- a field Study 
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Horwitz J, Machtei EE. 
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Introduction 
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Dental implants have become a standard therapy for partial and total 
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edentulism. Various implant designs have been studied for enhancement of 
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survival and success as well as ease of tratment.  
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Research Plan 
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The aim of the present study is to evaluate the 1-year survival and success of 
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MIS® C1 implants with a length of 10-15mm. 
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Specific Aims 
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1. To study 1 year implant survival rate C1 implants 
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2. To study 1 year implant bone level changes of C1 implants 
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C1 Implant Study 
January 24, 2013 
 
Protocol Version 3. January 24, 2013. 
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Materials and Methods: 
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Patients will be recruited by twelve dentists in locations of their respective 
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dental practices.  
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Inclusion criteria:  
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1. Age between 18-75. 
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2. Patient expresses his wish to restore the missing tooth/teeth with 
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implant therapy. 
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3. Partial edentulism with available bone height for dental implants ≥ 10mm 
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mm. 
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Exclusion criteria: 
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1. Contraindicating medical conditions such as uncontrolled diabetes, 
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untreated malignancies, pregnancy, previous/current bisphosphonate 
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therapy. 
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2. Untreated periodontal disease, untreated caries, PA pathology in contact 
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with the location of the prspective implant.   
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3. Major bone augmentation in conjunction with implant placement. 
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Localised bone augmentation in conjunction with implant placement, of up 
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to 3 mm on 1-2 aspects of the implant will be allowed.  
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4. One stage immediate loading/restoration. 
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C1 Implant Study 
January 24, 2013 
 
Protocol Version 3. January 24, 2013. 
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Patient and Location Assignment 
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12 implants will be allocated to each of the ten dentists, for a total of 120 
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implants. All the implants needed in the surgical area of the recruited patients 
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will be allowed into the study. 
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Clinical Measurements 
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The following data will be collected for each patient/implant: 
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1. Patient data including birthdate, health, surgery date. 
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2. Implants' length, diameter 
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3. Insertion torque 
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4. Periapical radiographs (at insertion, and twelve months post surgery). 
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5. Post operative complications and adverse events. 
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6. Periodontal data around Ramfjord teeth (16, 21, 24, 36, 41, 44)1: Plaque 
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index, Gingival Index, Probing depth in six sites and Bleeding on probing 
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in six sites, at baseline and twelve months post surgery. 
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C1 Implant Study 
January 24, 2013 
 
Protocol Version 3. January 24, 2013. 
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Study Design 
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A. A calibration meeting(s) of all participating dentists will precede study 
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commencement, in which the study design, inclusion criteria and surgical 
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techniques will be discussed and unified. All participating periodontists will 
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receive identical implant surgical kits to be used during the implant operative 
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procedures of the study patients as well as 10 MIS® C1 dental implants. 
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B. Patients attending the dental offices of the dentists will be screened for the 
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study. Those patients that meet the inclusion and exclusion criteria will be 
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offered to participate in the study. Patients will be examined and diagnosed, 
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cause-related therapy including caries treatment and all periodontal treatment 
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given, including oral hygiene instructions, scaling and root-planing and 
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periodontal surgery as necessary. Final eligibility will then be evaluated and 
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patients will be accepted into the study. 
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Study models, periapical and/or panoramic and/or CT radiographs will be used 
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for evaluation and treatment planning as necessary.  
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Surgery will be performed whereby patients will be given an antibiotic dose 1 
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hour prior to surgery, consisting of 875mg Augmentin+ 1.5g amoxicillin or 
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500mg Augmentin+ 1.5g amoxicillin or 2g amoxicillin, or, in cases of penicillin 
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allergy, 600mg of clindamycin. Implants will be installed and a healing abutment 
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will be connected and flaps sutured; implant type, length and diameter, and 
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periapical radiographs will be recorded. 
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C1 Implant Study 
January 24, 2013 
 
Protocol Version 3. January 24, 2013. 
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Patients will be given postoperative instructions, antibiotic and analgesic 
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therapy. Patients will be examined 7-10 days after surgery for suture removal 
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and then after 4 weeks, 3, 6 and 12 months post surgery. Maintenance 
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periodontal treatment will be provided at 1-month post surgery and then every 
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3 months. At 3-6 months interim implant success evaluated and implants will be 
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restored by their dentists. First year implant evaluation will be performed at 12 
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months post surgery and study termination evaluation will be performed at 36 
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months. Patients will pay the cost of treatment excluding the cost of the implant,  
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the implant abutment and the follow up appointments. All necessary data will be 
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recorded in a patient report booklet 
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Data management and analysis 
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Data collected will be reported in a patient report booklet, including the various 
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clinical parameters and adverse events, recorded during clinical examinations.  
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Periapical radiographs will be used for radiographic measurement of the 
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distance in mm between implant margin and alveolar bone crest at the distal and 
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mesial aspects of the implant 
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Following the completion of the study data will be analyzed with the 
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collaboration of the statistical unit at the Rambam Health Care Campus. 
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C1 Implant Study 
January 24, 2013 
 
Protocol Version 3. January 24, 2013. 
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References: 
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1 Ramfjord SP. Indices for prevalence and incidence of periodontal disease. J 
Periodontol 1959;30:51–9.