Survival and Success of MIS C1 Implants- a Field Study

NCT ID: NCT01707108

Last Updated: 2021-06-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-28

Study Completion Date

2018-10-01

Brief Summary

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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

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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.

Conditions

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Failure of Osseointegration of Dental Implant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dental Implants

Rehabilitation of missing teeth with Dental Implant (MIS Technologies)

Group Type EXPERIMENTAL

Dental Implant (MIS Technologies)

Intervention Type DEVICE

MIS Technologies Ltd. C1 Dental implants

Interventions

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Dental Implant (MIS Technologies)

MIS Technologies Ltd. C1 Dental implants

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Horwitz, DMD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Health Care Campus

Haifa, , Israel

Site Status

Countries

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Israel

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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0113-12-RMB CTIL

Identifier Type: -

Identifier Source: org_study_id

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