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Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement

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ClinicalTrials.gov Identifier: NCT03374813
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Mimetis Biomaterials S.L.

Study Description
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Brief 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 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).

Condition or disease Intervention/treatment Phase
Alveolar Ridge Preservation Device: MimetikOss (bone grafting surgery) Device: Bio-Oss (bone grafting surgery) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement: A Multicenter Randomized Controlled Trial.
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : March 22, 2019
Estimated Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Bone volume changes [ Time Frame: 6 months post grafting procedure ]
    Bone ridge horizontal and vertical change assessment by CBCT


Secondary Outcome Measures :
  1. Bone histological observation [ Time Frame: 6 months post grafting procedure ]
    Histomorphometric analysis of the tissue components

  2. Implant survival [ Time Frame: 4 months y 1 year post grafting procedure ]
    ISQ measurement and bone level changes analysis

  3. Implant survival [ Time Frame: 4 months y 1 year post grafting procedure ]
    Bone level changes analysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374813


Contacts
Contact: Victor Bergez +34644 32 46 07 cr@mimetis.com

Locations
Chile
Universidad de los Andes Recruiting
Santiago, Chile, 12455
Contact    +56 9 7101 0175      
Principal Investigator: Antonio Sanz         
Spain
Universitat Internacional de Catalunya Recruiting
Barcelona, Spain, 08017
Contact: Miguel Roig    +34935042000      
Principal Investigator: Miguel Roig         
Universidad de granada Recruiting
Granada, Spain, 18017
Contact: Pablo Galindo Moreno    +34958243795      
Principal Investigator: Pablo Galindo Moreno         
Clinica dental Triana Recruiting
Palmas de Gran Canaria, Spain, 35002
Contact    (+34)928364549      
Principal Investigator: Renzo Bellini         
Clínica Bustillo Recruiting
Pamplona, Spain, 31008
Contact: Angel Fernández Bustillo    +34948255400      
Principal Investigator: Angel Fernández Bustillo         
Universitat de Sevilla, Facultad de odontología Recruiting
Sevilla, Spain, 41009
Contact: Eugenio Velasco    +34954481131      
Principal Investigator: Eugenio Velasco         
Universidad de Valencia, Facultad de Medicina y Odontología Recruiting
Valencia, Spain, 46010
Contact: Maria Peñarrocha    +34963864144      
Principal Investigator: Maria Peñarrocha         
Sponsors and Collaborators
Mimetis Biomaterials S.L.
More Information
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Responsible Party: Mimetis Biomaterials S.L.
ClinicalTrials.gov Identifier: NCT03374813     History of Changes
Other Study ID Numbers: REST-ECL-2017-01
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mimetis Biomaterials S.L.:
Bone graft substitutes
Synthetic graft
Xenograft
Ridge preservation
Alveolar defect