NCT03457298

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

November 7, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

February 26, 2018

Last Update Submit

May 16, 2019

Conditions

Alveolar Ridge Augmentation, Dental Implants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes in Ridge height mm

    baseline( prior to augmentation) and 9 months (implant placement)

Study Arms (2)

Ossix Volumax

EXPERIMENTAL

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

Device: Ossix Volumax

FDBA with collagen membrane

ACTIVE COMPARATOR

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

Device: FDBA with collagen membrane

Interventions

Ossix VolumaxDEVICE

Ossix Volumax is intended to be used for Lateral ridge augmentation

Ossix Volumax
FDBA with collagen membraneDEVICE

freeze-dried bone allograft (FDBA) with collagen membrane

FDBA with collagen membrane

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus, Dept. of Periodontology

Haifa, 31096, Israel

RECRUITING

Study Officials

  • Eli Machtei, DMD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eli Machtei, DMD

CONTACT

9727772983machtei@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 7, 2018

Study Start

November 7, 2018

Primary Completion

April 1, 2020

Study Completion

July 1, 2020

Last Updated

May 20, 2019

Record last verified: 2019-05

Locations

IL(1)