Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®
ConditionRidge Augmentation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDatum Dental LTD
About this trial
This is a prospective randomized controlled parallel trial. The aim of this study is to evaluate bone formation and soft tissue healing after 4 and 8 months in patients with ridge deficiencies in simultaneous implantation approach. The trial will compare a (sugar cross linked) - SCL pericardium membrane OSSIX® Breeze vs native pericardium membrane (Jason®).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females, age 18 and above.
General good health (ASA 1 and ASA 2).
Adults with buccal bone defect, who are in need of implant placement, and going through a guided bone regeneration treatment.
Patient needs 1-3 implants.
Disqualifiers
Physical status ASA III or ASA IV.
General contraindications for dental and/or surgical treatments.
Inflammatory and autoimmune disease of the oral cavity.
Patients with known collagen hypersensitivity.
Trial design
Design model
Parallel
Treatments tested in this trial
OSSIX Breeze
Devicebarrier membrane
Jason membrane
Devicebarrier membrane
Treatment groups
65 Participants
are divided into 2 treatment groupsGroup A: OSSIX BreezeExperimental treatment 1 intervention
Group B: Jason membraneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
increase in bone gain
increase in bone gain (vertical and horizontal) in mm, 4 months after the implant placement in the augmented site. the measurment will be done according to radiographic images
Time frame
4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov