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Status unknownNCT03457298Updated May 20, 2019

Lateral Ridge Augmentation Using a Volume Maintaining Collagen Scaffold Versus Allograft With Collagen Membrane.

An interventional study of Ossix Volumax and FDBA with collagen membrane in Alveolar Ridge Augmentation, Dental Implants, sponsored by Rambam Health Care Campus. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-20.

Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Alveolar Ridge Augmentation, Dental Implants
03

In context

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients age 18 to 85 years of age.
  2. Alveolar ridge atrophy (\<5 mm) in the horizontal dimension requiring bone augmentation.
  3. Implant therapy is scheduled for this site.
  4. Willing to participate in the study and follow all the post-op visits.

Exclusion criteria

Exclusion Criteria:

  1. Systemic condition requiring prophylactic antibiotics.
  2. 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.
  3. The use of medication known to impair healing (clinician desecration).
  4. Unable to place implant for whatever reason.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Ossix Volumax

    lateral bone augmentation using volume maintaining collagen scaffold (Ossix Volumax)

    Device: Ossix Volumax

  • Active comparator
    FDBA with collagen membrane

    lateral bone augmentation using the current gold standard FDBA plus resorbable collagen membrane

    Device: FDBA with collagen membrane

Interventions

  • DeviceOssix Volumax

    Ossix Volumax is intended to be used for Lateral ridge augmentation

  • DeviceFDBA with collagen membrane

    freeze-dried bone allograft (FDBA) with collagen membrane

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: baseline( prior to augmentation) and 9 months (implant placement)

07

Study locations

1 of 1 sites recruiting
  • Rambam Health Care Campus, Dept. of Periodontology
    Haifa, 31096, Israel
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2018 (actual). Primary completion is estimated for Apr 2020, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2018
First posted
Mar 7, 2018
StartActual
Nov 7, 2018
Primary completionEst.
Apr 2020
CompletionEst.
Jul 2020
Last update
May 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03457298
Lead sponsor
Rambam Health Care Campus
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Nov 7, 2018
Primary completion
Apr 2020 (estimated)
Completion
Jul 2020 (estimated)
Last update
May 20, 2019

Study contacts

Eli Machtei, DMD
Contact
machtei@rambam.health.gov.il
9727772983
Eli Machtei, DMD
principal investigator · Rambam Health Care Campus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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