Failure of Osseointegration of Dental ImplantNCT01707108
Survival and Success of MIS C1 Implants- a Field Study
A study testing Dental Implant (MIS Technologies) in people with Failure of Osseointegration of Dental Implant, run by Rambam Health Care Campus at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Failure of Osseointegration of Dental Implant
- What is being tested?
- Dental Implant (MIS Technologies)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Jan 2013to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-75.
- Patient expresses his wish to restore the missing tooth/teeth with implant therapy.
- Partial edentulism with available bone height for dental implants ≥ 10mm mm.
Who cannot join
- Contraindicating medical conditions such as uncontrolled diabetes, untreated malignancies, pregnancy, previous/current bisphosphonate therapy.
- Untreated periodontal disease, untreated caries, periapical pathology in contact with the location of the perspective implant.
- 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.
- One stage immediate loading/restoration.
Trial locations and contacts
1 site in 1 country.
About this study
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
- To study 1-year and 3-year implant survival rate C1 implants
- To study 1-year and 3-year implant bone level changes of C1 implants
Read the 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:
- Patient data including birthdate, health, surgery date.
- Implant length, diameter
- Insertion torque
- Periapical radiographs (at insertion, and twelve months post surgery).
- Post operative complications and adverse events.
- 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.
- Being tested
- Dental Implant (MIS Technologies)
- Keywords
- dental implants, bone loss
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implant (MIS Technologies)Device
MIS Technologies Ltd. C1 Dental implants
| Study group | Role | What they receive |
|---|---|---|
| Dental Implants | Experimental | Rehabilitation of missing teeth with Dental Implant (MIS Technologies) Receives: Device: Dental Implant (MIS Technologies) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Rate
1 year survival rate
Measured: 1 year post implantation
Secondary outcomes (1)
1 Year Implant Bone Level Changes
bone change in millimeters after 1 year
Measured: 1 year post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study start28 Jan 2013
- Primary completionOct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Failure of Osseointegration of Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Horwitz, DMD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707108
- Sponsor's protocol ID
- 0113-12-RMB CTIL
- Status last verified
- May 2021
- First submitted
- 11 Oct 2012
- Last updated
- 15 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival and Success of MIS C1 Implants- a Field Study
- ClinicalTrials.gov ID
- NCT01707108
- Acronym / sponsor ID
- 0113-12-RMB CTIL
- Keywords
- dental implants, bone loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 28 Jan 2013 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Posted 15 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To study 1-year and 3-year implant survival rate C1 implants
- 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:
- Patient data including birthdate, health, surgery date.
- Implant length, diameter
- Insertion torque
- Periapical radiographs (at insertion, and twelve months post surgery).
- Post operative complications and adverse events.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental Implants | Experimental | Device: Dental Implant (MIS Technologies)Rehabilitation of missing teeth with Dental Implant (MIS Technologies) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18-75.
- Patient expresses his wish to restore the missing tooth/teeth with implant therapy.
- Partial edentulism with available bone height for dental implants ≥ 10mm mm.
Key exclusion criteria (4 listed)
- Contraindicating medical conditions such as uncontrolled diabetes, untreated malignancies, pregnancy, previous/current bisphosphonate therapy.
- Untreated periodontal disease, untreated caries, periapical pathology in contact with the location of the perspective implant.
- 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.
- One stage immediate loading/restoration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental Implant (MIS Technologies)MIS Technologies Ltd. C1 Dental implants | Device | Dental Implants |
Primary outcome
Survival Rate
Time frame: 1 year post implantation
1 year survival rate
1 secondary outcome
1 Year Implant Bone Level Changes
Time frame: 1 year post implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Horwitz, DMD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Implant (MIS Technologies) in people with Failure of Osseointegration of Dental Implant, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival Rate (time frame: 1 year post implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.