Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement

March 24, 2021 updated by: Mimetis Biomaterials S.L.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile, 12455
        • Universidad De Los Andes
  • Spain
      • Barcelona, Spain, 08017
        • Universitat Internacional de Catalunya
      • Granada, Spain, 18017
        • Universidad de Granada
      • Palmas de Gran Canaria, Spain, 35002
        • Clinica dental Triana
      • Pamplona, Spain, 31008
        • Clínica Bustillo
      • Sevilla, Spain, 41009
        • Universitat de Sevilla, Facultad de odontología
      • Valencia, Spain, 46010
        • Universidad de Valencia, Facultad de Medicina y Odontología
    • Las Palmas De Gran Canaria
      • Vecindario, Las Palmas De Gran Canaria, Spain, 35110
        • IOC Dental Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • >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).
  • 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.

Exclusion Criteria:

  • 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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: MimetikOss
Ridge preservation bone grafting after tooth extraction
Device: MimetikOss (bone grafting surgery)
Ridge preservation bone grafting after dental extraction.
ACTIVE_COMPARATOR: Bio-Oss
Ridge preservation bone grafting after tooth extraction
Device: Bio-Oss (bone grafting surgery)
Ridge preservation bone grafting after dental extraction.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bone volume changes
Time Frame: 6 months post grafting procedure
Bone ridge horizontal and vertical change assessment by CBCT
6 months post grafting procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bone histological observation
Time Frame: 6 months post grafting procedure
Histomorphometric analysis of the tissue components
6 months post grafting procedure
Implant survival
Time Frame: 4 months y 1 year post grafting procedure
ISQ measurement and bone level changes analysis
4 months y 1 year post grafting procedure
Implant survival
Time Frame: 4 months y 1 year post grafting procedure
Bone level changes analysis
4 months y 1 year post grafting procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mimetis Biomaterials S.L.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REST-ECL-2017-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings