Survival and Success of MIS C1 Implants- a Field Study

Rambam Health Care Campus

Status: Completed

Conditions: Failure of Osseointegration of Dental Implant

Treatments: Device: Dental Implant (MIS Technologies)

Study type: Interventional

Funder types: Other

Identifiers

NCT01707108

0113-12-RMB CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Dental Implants

Experimental group

Description:

Rehabilitation of missing teeth with Dental Implant (MIS Technologies)

Treatment:

Device: Dental Implant (MIS Technologies)