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

Alveolar Ridge Augmentation, Dental Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03457298
• Other study ID #: 0014-18-RMB CTIL
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: July 2020

Study information

• Verified date: May 2019
• Source: Rambam Health Care Campus
• Contact: Eli Machtei, DMD
• Phone: 9727772983
• Email: machtei[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Ridge Augmentation, Dental Implants

Intervention

Device:
• Ossix Volumax
Ossix Volumax is intended to be used for Lateral ridge augmentation
• FDBA with collagen membrane
freeze-dried bone allograft (FDBA) with collagen membrane

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus, Dept. of Periodontology	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)