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

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.

Study Overview

• Status: Unknown
• Conditions: Alveolar Ridge Augmentation, Dental Implants
• Intervention / Treatment: Device: Ossix Volumax; Device: FDBA with collagen membrane

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Recruiting
    • Rambam Health Care Campus, Dept. of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 0014-18-RMB CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No