Clinical trial NCT03374813: Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement
Official title: Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement: A Multicenter Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Ridge Preservation
Keywords: Bone graft substitutes
Synthetic graft
Xenograft
Ridge preservation
Alveolar defect
Lead sponsor: Mimetis Biomaterials S.L.
Sponsor class: INDUSTRY
First posted: 2017-12-15
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Bone volume changes
timeFrame: 6 months post grafting procedure
Secondary outcomes:
measure: Bone histological observation
timeFrame: 6 months post grafting procedure
measure: Implant survival
timeFrame: 4 months y 1 year post grafting procedure
measure: Implant survival
timeFrame: 4 months y 1 year post grafting procedure
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad de los Andes
city: Vecindario
country: Spain
facility: IOC Dental Clinic
state: Las Palmas De Gran Canaria
city: Barcelona
country: Spain
facility: Universitat Internacional de Catalunya
city: Granada
country: Spain
facility: Universidad de granada
city: Palmas de Gran Canaria
country: Spain
facility: Clinica dental Triana
city: Pamplona
country: Spain
facility: Clínica Bustillo
city: Sevilla
country: Spain
facility: Universitat de Sevilla, Facultad de odontología
city: Valencia
country: Spain
facility: Universidad de Valencia, Facultad de Medicina y Odontología
Study officials:
References: