Tooth LossH2015-1NCT02591706
Clinical Assessment of Dental Implant
A study testing MIS Implants in people with Tooth Loss, run by University of Liege at 1 site in Belgium.
Trial summary
Primary Endpoints : The implant survival and success rate of V3 and C1 implants will be compared. Implant success rate will be evaluated by measuring the peri-implant bone remodeling from baseline to 1 year post insertion. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- MIS Implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Feb 2015to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must have voluntarily signed the informed consent form before any study related action
- Age: 18 with one or more missing teeth in the maxillary area, seeking for implant therapy.
- Men/Women
- In good systemic health (ASA I/ II)
- Present with no contra indication against oral surgical interventions
- Patients required replacement of a single missing tooth. The tooth at the implant site(s) must have been extracted or lost at least 12 weeks before the date of implantation.
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- At least 10 mm of bone in the vertical dimension
- At least 6 mm of bone in the bucco-lingual dimension.
- No need for bone augmentation procedure in any of the dimensions
- Full mouth plaque score (FMPI) lower or equal than 25%
Who cannot join
- Autoimmune disease require medical treatment
- Medical conditions requiring prolonged use of steroids
- Use of Bisphosphonate intravenously or more then
- Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
- Current pregnancy or breastfeeding women
- Alcoholism or chronically drug abuse
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- Immunocompromised patients
- Uncontrolled Diabetes
- Smokers
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Assessment of V3 Implant: A Randomized Controlled Trial
Primary Endpoints : The implant survival and success rate of V3 and C1 implants will be compared. Implant success rate will be evaluated by measuring the peri-implant bone remodeling from baseline to 1 year post insertion.
The hypothesis is those implant survival rates of the test (V3) and control group (C1) are similar and that test V3 implant allows less peri-implant bone loss.
Read more
Secondary Endpoints : The thickness of hard tissue in the buccal aspect of the V3 and C1 implants will be compared. The bone thickness will be measured in cone beam computerized tomography (CBCT) on the day of implantation, 4 and at one year after the final restoration.
The hypothesis is that V3 implant allows thicker bone dimension in the cervical area.
- Conditions
- Tooth Loss
- Being tested
- MIS Implants
- Keywords
- Single missing tooth, Implants, Peri-implant bone remodeling, Bone thickness, Thickness of soft tissue
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIS ImplantsDevice
Also called MIS Implants Technologies
The implantation procedure will be carried out according to a standard surgical protocol, and according the manufacture protocol. Patient will be randomly assigned to one of the two groups after flap opening. The implant stability will be measured using the wench key and recorded in N/cm. The implants will be covered with healing abutments for trans-gingival healing for a period of 4 months. The area will be sutured with thin nylon sutures for a primary passive fit closure. Immediately after the surgery the patient will perform a CBCT of the treated area with a cotton roll on the buccal side in order to be able to evaluate the buccal soft tissue thickness.
| Study group | Role | What they receive |
|---|---|---|
| Dental implant (C1) | Active comparator | Internal Conical Connection: The C1 has a six-position cone index, except for the C1 narrow platform that has a four-position cone index. The conical connection is 2.00mm in depth, with a 12° cone. As a result of our meticulous manufacturing process a perfect fit between the implant and the abutment is achieved, eliminating micro-movements and minimizing bone resorption.
Patient will be randomly assigned to one of the two groups after flap opening. Receives: Device: MIS Implants |
| Dental implant (V3) | Experimental | The unique triangular shape of the coronal portion of the V3 implant results in less titanium and more bone and soft tissue visible in the esthetic zone, for a restorative-driven approach and easier soft tissue management. The V3 provides doctors with a more advantageous starting point; where greater volume of bone and soft tissue is achieved at the onset of implant placement.
Patient will be randomly assigned to one of the two groups after flap opening. Receives: Device: MIS Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of implant survival and success rate of V3 and C1 implants
Implant success rate will be evaluated by measuring the peri-implant bone remodeling from baseline to 1 year post insertion. The hypothesis is those implant survival rates of the test (V3) and similar and that test V3 implant allows less peri-implant bone loss.
Measured: 1 year
Secondary outcomes (1)
Comparison of the thickness of hard tissue in the buccal aspect of the V3 and C1 implants
The bone thickness will be measured in cone beam computerized tomography (CBCT) on the day of implantation, 4 and at one year after the final restoration.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start2 Feb 2015
- Primary completionMar 2016
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- MIS Implant Technologies, Ltd
- Responsible party
- Principal investigator, Dr. France LAMBERT, University of Liege
- Investigators
- France LAMBERT, Study director, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591706
- Sponsor's protocol ID
- H2015-1
- Acronym
- H2015-1
- Status last verified
- May 2022
- First submitted
- 9 Oct 2015
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of V3 Implant: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02591706
- Acronym / sponsor ID
- H2015-1 / H2015-1
- Conditions
- Tooth Loss
- Keywords
- Single missing tooth, Implants, Peri-implant bone remodeling, Bone thickness, Thickness of soft tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- MIS Implant Technologies, Ltd
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Endpoints : The implant survival and success rate of V3 and C1 implants will be compared. Implant success rate will be evaluated by measuring the peri-implant bone remodeling from baseline to 1 year post insertion.
The hypothesis is those implant survival rates of the test (V3) and control group (C1) are similar and that test V3 implant allows less peri-implant bone loss.
Secondary Endpoints : The thickness of hard tissue in the buccal aspect of the V3 and C1 implants will be compared. The bone thickness will be measured in cone beam computerized tomography (CBCT) on the day of implantation, 4 and at one year after the final restoration.
The hypothesis is that V3 implant allows thicker bone dimension in the cervical area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental implant (C1) | Active comparator | Device: MIS ImplantsInternal Conical Connection: The C1 has a six-position cone index, except for the C1 narrow platform that has a four-position cone index. The conical connection is 2.00mm in depth, with a 12° cone. As a result of our meticulous manufacturing process a perfect fit between the implant and the abutment is achieved, eliminating micro-movements and minimizing bone resorption. Patient will be randomly assigned to one of the two groups after flap opening. |
| Dental implant (V3) | Experimental | Device: MIS ImplantsThe unique triangular shape of the coronal portion of the V3 implant results in less titanium and more bone and soft tissue visible in the esthetic zone, for a restorative-driven approach and easier soft tissue management. The V3 provides doctors with a more advantageous starting point; where greater volume of bone and soft tissue is achieved at the onset of implant placement. Patient will be randomly assigned to one of the two groups after flap opening. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject must have voluntarily signed the informed consent form before any study related action
- Age: 18 with one or more missing teeth in the maxillary area, seeking for implant therapy.
- Men/Women
- In good systemic health (ASA I/ II)
- Present with no contra indication against oral surgical interventions
Key exclusion criteria (10 listed)
- Autoimmune disease require medical treatment
- Medical conditions requiring prolonged use of steroids
- Use of Bisphosphonate intravenously or more then
- Infection (local or systemic) - patient with gingivitis or active local infection will undergo a medical treatment prior to his entrance to the study, each individual will be evaluated prior to study procedure for suitability, in case of systemic infection the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
- Current pregnancy or breastfeeding women
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 |
|---|---|---|
| MIS ImplantsAlso: MIS Implants TechnologiesThe implantation procedure will be carried out according to a standard surgical protocol, and according the manufacture protocol. Patient will be randomly assigned to one of the two groups after flap opening. The implant stability will be measured using the wench key and recorded in N/cm. The implants will be covered with healing abutments for trans-gingival healing for a period of 4 months. The area will be sutured with thin nylon sutures for a primary passive fit closure. Immediately after the surgery the patient will perform a CBCT of the treated area with a cotton roll on the buccal side in order to be able to evaluate the buccal soft tissue thickness. | Device | Dental implant (C1), Dental implant (V3) |
Primary outcome
Comparison of implant survival and success rate of V3 and C1 implants
Time frame: 1 year
Implant success rate will be evaluated by measuring the peri-implant bone remodeling from baseline to 1 year post insertion. The hypothesis is those implant survival rates of the test (V3) and similar and that test V3 implant allows less peri-implant bone loss.
1 secondary outcome
Comparison of the thickness of hard tissue in the buccal aspect of the V3 and C1 implants
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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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.
France LAMBERT study director
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIS Implants in people with Tooth Loss, run by University of Liege at 1 site in Belgium.
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 10 inclusion and 10 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 19 May 2022. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of implant survival and success rate of V3 and C1 implants (time frame: 1 year). 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 19 May 2022.