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

Not Applicable

• Conditions: Alveolar Ridge Augmentation, Dental Implants
• Interventions: Device: FDBA with collagen membrane; Device: Ossix Volumax

• Registration Number: NCT03457298
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

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 Timeline

• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-07
• Study Start: 2018-11-07
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-20
• Primary Completion: 2020-04
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FDBA with collagen membrane	FDBA with collagen membrane	lateral bone augmentation using the current gold standard FDBA plus resorbable collagen membrane
Ossix Volumax	Ossix Volumax	lateral bone augmentation using volume maintaining collagen scaffold (Ossix Volumax)

Primary Outcome Measures

Name	Time	Method
Changes in socket width mm	baseline( prior to augmentation) and 9 months (implant placement)	Clinical measurement of the ridge width as -2, -5 \& -8 mm from crest at the Region of interest (ROI) using a caliper

Secondary Outcome Measures

Name	Time	Method
Changes in Ridge height mm	baseline( prior to augmentation) and 9 months (implant placement)	Ridge height from a pre-determined landmark using a 15mm Dental probe

Trial Locations

Locations (1)

Rambam Health Care Campus, Dept. of Periodontology; 🇮🇱 Haifa, Israel