Alveolar Ridge PreservationNCT03374813
Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement
A study testing MimetikOss (bone grafting surgery) and Bio-Oss (bone grafting surgery) in people with Alveolar Ridge Preservation, run by Mimetis Biomaterials S.L. at 8 sites in 2 countries.
Trial summary
The hypothesis tested in this clinical trial is that a biomimetic synthetic bone graft substitute (MimetikOss, Mimetis Biomaterials) with similar properties to those of human bone can reach a clinical outcome non inferior to that of a deproteinized bovine bone matrix bone graft substitute (Bio-Oss, Geistlisch) in an… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Preservation
- What is being tested?
- MimetikOss (bone grafting surgery) and Bio-Oss (bone grafting surgery)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 16 Nov 2017to 15 Dec 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years old.
- Able to sign an informed consent form.
- Patients in need of socket preservation presenting 4 wall defects on premolar and molar zone in the maxilla or in the mandible.
- Healthy extraction site (no infected walls).
- The height of root molar bone support must be > 6 mm. The height of root molar bone support plus the bone height between the most apical root part and the sinus floor must be > 3 mm. As described in the picture below. Molar roots must be surgically separated previous to extraction
- Only 4 walled defects are included (3mm max of difference between buccal and lingual plate height).
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- Presence of opposite occlusal dentition with natural roots in the area intended for extraction and implant placement.
- Natural roots are adjacent to implant site.
- If patient presents more than 1 defect that could be included in the study, only one will be part of the study, the other sites will be treated with the standard of care.
- Patient in good physical health.
- The subject is willing and able to comply with all study-related procedures (such as exercising oral hygiene and attending all follow-up procedures).
- Full-mouth bleeding score (FMBS) lower than 25%.
- The subject is suitable for a 2-stage surgical procedure.
Who cannot join
- Patients with premolar extraction due to the root fracture that present infected two wall type defect.
- Patients presenting the defect in the molar and/or premolar region of the maxilla with the concomitant need of sinus lift.
- Absence of adjacent teeth.
- Lack of opposite occluding dentition in the area intended for extraction and subsequent implant placement.
- 3 wall (or less) defects.
- Presence of bone dehiscence superior to 3 mm.
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- Fenestration in the area intended to treat.
- Prior bone augmentation in the area planned for treatment (i.e ridge preservation).
- History of systemic diseases that would contraindicate oral surgical treatment or any other disease or medication that might have an influence on the involved tissues, such as intake of bisphosphonates, treatment with heparine, osteogenesis imperfecta, osteoporosis etc.
- Autoimmune disease (Rheumatoid polyarthritis, Crohn, Lupus, Sarcoidosis etc).
- Health conditions, which do not permit the surgical (including anaesthesia) or restorative procedure.
- Pregnant or breast feeding women.
- Any disorders directly in the planned implant area such as previous tumours, radiation or chronic bone disease.
- More than three teeth with full crown coverage in the dental arch (mandible or maxilla of the implant to be placed).
- Any ongoing application of interfering medication (steroid therapy, bisphosphonate, Paclitaxel, methotrexate etc).
- Active periodontal disease involving the residual dentition.
- Alcohol or drug abuse as noted in subject records or in subject history.
- Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or history.
- Heavy smoking (> 10 cigarettes per day).
- Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 6.8%.
- Poor compliance.
- Mucosal diseases in the areas to be treated.
- Subject is involved in other clinical trial.
- Subject suffer severe bruxism
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Spain7 sites
Universitat Internacional de Catalunya
Barcelona, 08017
Universidad de granada
Granada, 18017
Clinica dental Triana
Las Palmas de Gran Canaria, 35002
Clínica Bustillo
Pamplona, 31008
Universitat de Sevilla, Facultad de odontología
Seville, 41009
Universidad de Valencia, Facultad de Medicina y Odontología
Valencia, 46010
IOC Dental Clinic
Vecindario, Las Palmas de Gran Canaria, 35110
About this study
Official title: Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement: A Multicenter Randomized Controlled Trial.
The hypothesis tested in this clinical trial is that a biomimetic synthetic bone graft substitute (MimetikOss, Mimetis Biomaterials) with similar properties to those of human bone can reach a clinical outcome non inferior to that of a deproteinized bovine bone matrix bone graft substitute (Bio-Oss, Geistlisch) in an alveolar ridge preservation procedure followed by implant placement in terms of bone volume changes (primary end point), bone histological observation implant stability and bone level changes (secondary end points).
- Conditions
- Alveolar Ridge Preservation
- Being tested
- MimetikOss (bone grafting surgery), Bio-Oss (bone grafting surgery)
- Keywords
- Bone graft substitutes, Synthetic graft, Xenograft, Ridge preservation, Alveolar defect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MimetikOss (bone grafting surgery)Device
Ridge preservation bone grafting after dental extraction.
Bio-Oss (bone grafting surgery)Device
Ridge preservation bone grafting after dental extraction.
| Study group | Role | What they receive |
|---|---|---|
| MimetikOss | Experimental | Ridge preservation bone grafting after tooth extraction Receives: Device: MimetikOss (bone grafting surgery) |
| Bio-Oss | Active comparator | Ridge preservation bone grafting after tooth extraction Receives: Device: Bio-Oss (bone grafting surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume changes
Bone ridge horizontal and vertical change assessment by CBCT
Measured: 6 months post grafting procedure
Secondary outcomes (3)
Bone histological observation
Histomorphometric analysis of the tissue components
Measured: 6 months post grafting procedure
Implant survival
ISQ measurement and bone level changes analysis
Measured: 4 months y 1 year post grafting procedure
Implant survival
Bone level changes analysis
Measured: 4 months y 1 year post grafting procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start16 Nov 2017
- Primary completion22 Apr 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge PreservationStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mimetis Biomaterials S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374813
- Sponsor's protocol ID
- REST-ECL-2017-01
- Status last verified
- Mar 2021
- First submitted
- 5 Dec 2017
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement: A Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03374813
- Acronym / sponsor ID
- REST-ECL-2017-01
- Conditions
- Alveolar Ridge Preservation
- Keywords
- Bone graft substitutes, Synthetic graft, Xenograft, Ridge preservation, Alveolar defect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Mimetis Biomaterials S.L.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 22 Apr 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 15 Dec 2017 (actual)
- 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.
The hypothesis tested in this clinical trial is that a biomimetic synthetic bone graft substitute (MimetikOss, Mimetis Biomaterials) with similar properties to those of human bone can reach a clinical outcome non inferior to that of a deproteinized bovine bone matrix bone graft substitute (Bio-Oss, Geistlisch) in an alveolar ridge preservation procedure followed by implant placement in terms of bone volume changes (primary end point), bone histological observation implant stability and bone level changes (secondary end points).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MimetikOss | Experimental | Device: MimetikOss (bone grafting surgery)Ridge preservation bone grafting after tooth extraction |
| Bio-Oss | Active comparator | Device: Bio-Oss (bone grafting surgery)Ridge preservation bone grafting after tooth extraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- >18 years old.
- Able to sign an informed consent form.
- Patients in need of socket preservation presenting 4 wall defects on premolar and molar zone in the maxilla or in the mandible.
- Healthy extraction site (no infected walls).
- The height of root molar bone support must be > 6 mm. The height of root molar bone support plus the bone height between the most apical root part and the sinus floor must be > 3 mm. As described in the picture below. Molar roots must be surgically separated previous to extraction
Key exclusion criteria (24 listed)
- Patients with premolar extraction due to the root fracture that present infected two wall type defect.
- Patients presenting the defect in the molar and/or premolar region of the maxilla with the concomitant need of sinus lift.
- Absence of adjacent teeth.
- Lack of opposite occluding dentition in the area intended for extraction and subsequent implant placement.
- 3 wall (or less) defects.
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 |
|---|---|---|
| MimetikOss (bone grafting surgery)Ridge preservation bone grafting after dental extraction. | Device | MimetikOss |
| Bio-Oss (bone grafting surgery)Ridge preservation bone grafting after dental extraction. | Device | Bio-Oss |
Primary outcome
Bone volume changes
Time frame: 6 months post grafting procedure
Bone ridge horizontal and vertical change assessment by CBCT
3 secondary outcomes
Bone histological observation
Time frame: 6 months post grafting procedure
Implant survival
Time frame: 4 months y 1 year post grafting procedure
Implant survival
Time frame: 4 months y 1 year post grafting procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MimetikOss (bone grafting surgery) and Bio-Oss (bone grafting surgery) in people with Alveolar Ridge Preservation, run by Mimetis Biomaterials S.L. at 8 sites in 2 countries.
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 13 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Chile. 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?
Results are not available in the source record.
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?
Bone volume changes (time frame: 6 months post grafting procedure). 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 25 Mar 2021.