Survival and Success of MIS C1 Implants- a Field Study

Failure of Osseointegration of Dental Implant Clinical Trial

Official title:

Survival and Success of MIS C1 Implants- a Field Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707108
• Other study ID #: 0113-12-RMB CTIL
• Status: Completed
• Phase: N/A
• Start date: January 28, 2013
• Est. completion date: October 1, 2018

Study information

• Verified date: May 2021
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 1, 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Failure of Osseointegration of Dental Implant

Intervention

Device:
• Dental Implant (MIS Technologies)
MIS Technologies Ltd. C1 Dental implants

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival Rate	1 year survival rate	1 year post implantation
Secondary	1 Year Implant Bone Level Changes	bone change in millimeters after 1 year	1 year post implantation