Alveolar Ridge Augmentation, Dental ImplantsNCT03457298
Lateral Ridge Augmentation Using a Volume Maintaining Collagen Scaffold Versus Allograft With Collagen Membrane.
A study testing Ossix Volumax and FDBA with collagen membrane in people with Alveolar Ridge Augmentation, Dental Implants, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The aim of the current study is to compare lateral bone augmentation using the current gold standard (FDBA plus resorbable collagen membrane) versus Ossix Volumax as a stand-alone material. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation, Dental Implants
- What is being tested?
- Ossix Volumax and FDBA with collagen membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Nov 2018to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients age 18 to 85 years of age.
- Alveolar ridge atrophy (<5 mm) in the horizontal dimension requiring bone augmentation.
- Implant therapy is scheduled for this site.
- Willing to participate in the study and follow all the post-op visits.
Who cannot join
- Systemic condition requiring prophylactic antibiotics.
- The Introduction( I.V.) use of medication related osteonecrosis of the jaw ( MRONJ) or the use of such medication Per Os (P.O.) for five or more years, patients with at least three month drug holiday with a C-terminal cross-linking telopeptide (CTX) > 150 pg/ml are eligible.
- The use of medication known to impair healing (clinician desecration).
- Unable to place implant for whatever reason.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus, Dept. of Periodontology
Haifa, 31096
prof. Eli Machtei, DMD, 9720545503199, machtei@rambam.health.gov.il
About this study
Official title: Lateral Ridge Augmentation Using a Volume Maintaining Collagen Scaffold (Ossix Volumax) Versus Freeze-dried Bone Allograft (FDBA) With Collagen Membrane
The aim of the current study is to compare lateral bone augmentation using the current gold standard (FDBA plus resorbable collagen membrane) versus Ossix Volumax as a stand-alone material.
Read the detailed description
One of the major problems in implant therapy is the need to regenerate bone after its resorption because of periodontal disease, traumatic extraction or surgical removal associated with treatment of invasive lesions.
Ossix Volumax is a novel volume maintaining collagen scaffold designed for bone augmentation in the atrophic ridge. It is 1-2 mm in thickness and undergoes mineralization progressing into ossification.
Thirty subjects requiring lateral bone augmentation of the maxilla or the mandible will be recruited study: Of these, twenty will be recruited and treated at the School of Dental Medicine, Harvard University, Boston, USA and ten (10) at the School of Graduate Dentistry, Rambam health care campus, Haifa, Israel.
Hypothesis:
The use of Ossix Volumax as a stand-alone augmentation material will results similar increase in the ridge width and volume compared to FDBA and barrier membrane when coupled together.
- Being tested
- Ossix Volumax, FDBA with collagen membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ossix VolumaxDevice
Ossix Volumax is intended to be used for Lateral ridge augmentation
FDBA with collagen membraneDevice
freeze-dried bone allograft (FDBA) with collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| Ossix Volumax | Experimental | lateral bone augmentation using volume maintaining collagen scaffold (Ossix Volumax) Receives: Device: Ossix Volumax |
| FDBA with collagen membrane | Active comparator | lateral bone augmentation using the current gold standard FDBA plus resorbable collagen membrane Receives: Device: FDBA with collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in socket width mm
Clinical measurement of the ridge width as -2, -5 \& -8 mm from crest at the Region of interest (ROI) using a caliper
Measured: baseline( prior to augmentation) and 9 months (implant placement)
Secondary outcomes (1)
Changes in Ridge height mm
Ridge height from a pre-determined landmark using a 15mm Dental probe
Measured: baseline( prior to augmentation) and 9 months (implant placement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start7 Nov 2018
- Primary completionApr 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge Augmentation, Dental ImplantsStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eli Machtei, DMD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457298
- Sponsor's protocol ID
- 0014-18-RMB CTIL
- Status last verified
- May 2019
- First submitted
- 26 Feb 2018
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Ridge Augmentation Using a Volume Maintaining Collagen Scaffold (Ossix Volumax) Versus Freeze-dried Bone Allograft (FDBA) With Collagen Membrane
- ClinicalTrials.gov ID
- NCT03457298
- Acronym / sponsor ID
- 0014-18-RMB CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 7 Mar 2018 (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.
The aim of the current study is to compare lateral bone augmentation using the current gold standard (FDBA plus resorbable collagen membrane) versus Ossix Volumax as a stand-alone material.
Detailed description
One of the major problems in implant therapy is the need to regenerate bone after its resorption because of periodontal disease, traumatic extraction or surgical removal associated with treatment of invasive lesions.
Ossix Volumax is a novel volume maintaining collagen scaffold designed for bone augmentation in the atrophic ridge. It is 1-2 mm in thickness and undergoes mineralization progressing into ossification.
Thirty subjects requiring lateral bone augmentation of the maxilla or the mandible will be recruited study: Of these, twenty will be recruited and treated at the School of Dental Medicine, Harvard University, Boston, USA and ten (10) at the School of Graduate Dentistry, Rambam health care campus, Haifa, Israel.
Hypothesis:
The use of Ossix Volumax as a stand-alone augmentation material will results similar increase in the ridge width and volume compared to FDBA and barrier membrane when coupled together.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ossix Volumax | Experimental | Device: Ossix Volumaxlateral bone augmentation using volume maintaining collagen scaffold (Ossix Volumax) |
| FDBA with collagen membrane | Active comparator | Device: FDBA with collagen membranelateral bone augmentation using the current gold standard FDBA plus resorbable collagen membrane |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients age 18 to 85 years of age.
- Alveolar ridge atrophy (<5 mm) in the horizontal dimension requiring bone augmentation.
- Implant therapy is scheduled for this site.
- Willing to participate in the study and follow all the post-op visits.
Key exclusion criteria (4 listed)
- Systemic condition requiring prophylactic antibiotics.
- The Introduction( I.V.) use of medication related osteonecrosis of the jaw ( MRONJ) or the use of such medication Per Os (P.O.) for five or more years, patients with at least three month drug holiday with a C-terminal cross-linking telopeptide (CTX) > 150 pg/ml are eligible.
- The use of medication known to impair healing (clinician desecration).
- Unable to place implant for whatever reason.
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 VolumaxOssix Volumax is intended to be used for Lateral ridge augmentation | Device | Ossix Volumax |
| FDBA with collagen membranefreeze-dried bone allograft (FDBA) with collagen membrane | Device | FDBA with collagen membrane |
Primary outcome
Changes in socket width mm
Time frame: baseline( prior to augmentation) and 9 months (implant placement)
Clinical measurement of the ridge width as -2, -5 \& -8 mm from crest at the Region of interest (ROI) using a caliper
1 secondary outcome
Changes in Ridge height mm
Time frame: baseline( prior to augmentation) and 9 months (implant placement)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
Related trials for Alveolar Ridge Augmentation, Dental Implants
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Evaluation of Guided Tissue Regeneration With Autogenous Bone Chips and CGF During Implant Placement
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Comparative Analysis of 2 Bone Graft Materials in Socket Preservation
Socket Preservation, Alveolar Ridge Augmentation
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Cross-linked Volume-stable Collagen Matrix Versus Connective Tissue Graft At Implant Site.
Edentulous Alveolar Ridge Atrophy, Soft Tissue Augmentation At Dental Implants
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. This study is not recruiting at the moment.
Eli Machtei, DMD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ossix Volumax and FDBA with collagen membrane in people with Alveolar Ridge Augmentation, Dental Implants, run by Rambam Health Care Campus at 1 site in Israel.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eli Machtei, DMD (9727772983, machtei@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in socket width mm (time frame: baseline( prior to augmentation) and 9 months (implant placement)). 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 20 May 2019; AzTrials last refreshed its copy on 28 Oct 2026.