Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement

• ClinicalTrials.gov Identifier: NCT03374813
• Recruitment Status: Active, not recruiting
• First Posted: December 15, 2017
• Last Update Posted: March 25, 2021
• Sponsor: Mimetis Biomaterials S.L.
• Information provided by (Responsible Party): Mimetis Biomaterials S.L.

Study Description

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 102 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: April 22, 2021
• Estimated Study Completion Date: December 15, 2021

Arms and Interventions

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

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

• 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

Locations

Chile

Universidad de los Andes

Santiago, Chile, 12455

Spain

IOC Dental Clinic

Vecindario, Las Palmas De Gran Canaria, Spain, 35110

Universitat Internacional de Catalunya

Barcelona, Spain, 08017

Universidad de granada

Granada, Spain, 18017

Clinica dental Triana

Palmas de Gran Canaria, Spain, 35002

Clínica Bustillo

Pamplona, Spain, 31008

Universitat de Sevilla, Facultad de odontología

Sevilla, Spain, 41009

Universidad de Valencia, Facultad de Medicina y Odontología

Valencia, Spain, 46010

Sponsors and Collaborators

Mimetis Biomaterials S.L.

More Information

• Responsible Party: Mimetis Biomaterials S.L.
• ClinicalTrials.gov Identifier: NCT03374813
• Other Study ID Numbers: REST-ECL-2017-01
• First Posted: December 15, 2017
• Last Update Posted: March 25, 2021
• Last Verified: March 2021

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