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

Rambam Health Care Campus

Status: Unknown

Conditions: Alveolar Ridge Augmentation, Dental Implants

Treatments: Device: FDBA with collagen membrane; Device: Ossix Volumax

Study type: Interventional

Funder types: Other

Identifiers

NCT03457298

0014-18-RMB CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Ossix Volumax

Experimental group

Description:

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

Treatment:

Device: Ossix Volumax

FDBA with collagen membrane

Active Comparator group

Description:

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

Treatment:

Device: FDBA with collagen membrane