Ridge AugmentationNCT05584566
Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason®
A study testing OSSIX Breeze and Jason membrane in people with Ridge Augmentation, run by Datum Dental LTD at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ridge Augmentation
- What is being tested?
- OSSIX Breeze and Jason membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Dec 2022to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Good oral hygiene (full mouth plaque index <25%).
- Adequate control of inflammation (full mouth bleeding on probing <25%).
- Patient is willing to sign an informed consent and participate in the clinical study.
- 10 8. Patient is able to understand and comply with the study related procedures, such as exercising good oral hygiene and attending all follow-up examinations.
Who cannot join
- 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.
- Patients with sensitivity to porcine-derived materials.
- Patients suffering from autoimmune diseases and connective tissue diseases, such as: systemic lupus erythematosus, dermatomyositis, etc.
Show all 16Show fewer
- Acute infection in the oral cavity or acute inflammation at the implantation site.
- General diseases, where measures of stomatology, maxillo-facial surgery, implantology, periodontology, endodontology or other measures of oral surgery are contraindicated.
- Disease of oral mucosa.
- Uncontrolled periodontal disease
- Concurrent or previous radiotherapy of head area.
- Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
- Smoking (over 10 cigarettes a day).
- Pregnant or lactating women.
- Women of childbearing potential, who are not using a highly effective method of birth control.
- Participation in another investigational device, drug, or biologics study within the last 24 weeks prior to study entry.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Israel2 sites, 2 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem
Asaf Wilenski, Prof
- Recruiting
Rabin Medical Center
Petah Tikva, 4928451
Gabi Chaushu, prof, 0524685734, GavrielCe@clalit.org.il
United Kingdom1 site, 1 recruiting
- Recruiting
University of Birmingham
Birmingham
Thomas Dietrich, Prof
About this study
Official title: Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason® Membrane in Simultaneous Implantations. A Prospective, Randomized Controlled 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®).
- Conditions
- Ridge Augmentation
- Being tested
- OSSIX Breeze, Jason membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSSIX BreezeDevice
barrier membrane
Jason membraneDevice
barrier membrane
| Study group | Role | What they receive |
|---|---|---|
| OSSIX Breeze | Experimental | Not described Receives: Device: OSSIX Breeze |
| Jason membrane | Active comparator | Not described Receives: Device: Jason membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Dec 2022
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Datum Dental LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584566
- Sponsor's protocol ID
- DD-OG-01
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2022
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason® Membrane in Simultaneous Implantations. A Prospective, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05584566
- Acronym / sponsor ID
- DD-OG-01
- Conditions
- Ridge Augmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Datum Dental LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSSIX Breeze | Experimental | Device: OSSIX Breeze |
| Jason membrane | Active comparator | Device: Jason membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Good oral hygiene (full mouth plaque index <25%).
Key exclusion criteria (16 listed)
- 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.
- Patients with sensitivity to porcine-derived materials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSSIX Breezebarrier membrane | Device | OSSIX Breeze |
| Jason membranebarrier membrane | Device | Jason membrane |
Primary outcome
increase in bone gain
Time frame: 4 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
Related trials for Ridge Augmentation
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix
Acellular Dermal Matrix, Bone Grafting
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OSSIX Breeze and Jason membrane in people with Ridge Augmentation, run by Datum Dental LTD at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gavriel Chaushu, prof (+97239377207, GavrielCe@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase in bone gain (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.