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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Lateral Ridge Augmentation Using a Volume Maintaining Collagen Scaffold (Ossix Volumax) Versus Freeze-dried Bone Allograft (FDBA) With Collagen Membrane

Conditions
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Alveolar Ridge Augmentation, Dental Implants

Intervention / Treatment
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* Device: Ossix Volumax
* Device: FDBA with collagen membrane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ossix Volumax<br>lateral bone augmentation using volume maintaining collagen scaffold (Ossix Volumax) | Device: Ossix Volumax<br>* Ossix Volumax is intended to be used for Lateral ridge augmentation<br>|
| Active Comparator: FDBA with collagen membrane<br>lateral bone augmentation using the current gold standard FDBA plus resorbable collagen membrane | Device: FDBA with collagen membrane<br>* freeze-dried bone allograft (FDBA) with collagen membrane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline( prior to augmentation) and 9 months (implant placement) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Ridge height mm | Ridge height from a pre-determined landmark using a 15mm Dental probe | baseline( prior to augmentation) and 9 months (implant placement) |