Survival and Success of MIS C1 Implants- a Field Study

Not Applicable

Completed

• Conditions: Failure of Osseointegration of Dental Implant
• Interventions: Device: Dental Implant (MIS Technologies)

• Registration Number: NCT01707108
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Study Start: 2013-01-28
• Primary Completion: 2018-10
• Study Completion: 2018-10-01
• Results First Submitted: 2021-03-10
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-19
• Last Update Submitted: 2021-05-19
• Results First Posted: 2021-06-15
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dental Implants	Dental Implant (MIS Technologies)	Rehabilitation of missing teeth with Dental Implant (MIS Technologies)

Primary Outcome Measures

Name	Time	Method
Survival Rate	1 year post implantation	1 year survival rate

Secondary Outcome Measures

Name	Time	Method
1 Year Implant Bone Level Changes	1 year post implantation	bone change in millimeters after 1 year

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel