Failure of Osseointegration of Dental Implant
Conditions
Keywords
dental implants, bone loss
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
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.
Interventions
DEVICEDental Implant (MIS Technologies)
MIS Technologies Ltd. C1 Dental implants
Sponsors
Rambam Health Care Campus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate | 1 year post implantation | 1 year survival rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1 Year Implant Bone Level Changes | 1 year post implantation | bone change in millimeters after 1 year |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dental Implants Rehabilitation of missing teeth with Dental Implant (MIS Technologies)
Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants | 60 |
| Dental Implants Rehabilitation of missing teeth with Dental Implant (MIS Technologies)
Dental Implant (MIS Technologies): MIS Technologies Ltd. C1 Dental implants | 117 |
| Total | 177 |
Baseline characteristics
| Characteristic | Dental Implants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants |
| Region of Enrollment Israel | 60 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Survival Rate
1 year survival rate
Time frame: 1 year post implantation
Population: Fifteen patients (25%) received 1 implant and 45 patients (75%) received 2 or more implants.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Dental Implants | Survival Rate | 115 dental implants |
Secondary
1 Year Implant Bone Level Changes
bone change in millimeters after 1 year
Time frame: 1 year post implantation
Population: 117 implants in 60 patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dental Implants | 1 Year Implant Bone Level Changes | 0.54 millimeters | Standard Deviation 0.55 |