NCT01654627

Brief Summary

The purpose of this study is to examine the safety and usefulness of the Regenecure guided bone regeneration membrane for stimulating bone growth in patients that don't have enough bone for dental implant placement. The study will include 16 patients in each group, 20 non-smokers and 12 smokers, a total of 32 patients will participate in the study.

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
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2013

Typical duration for phase_1

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

July 26, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 27, 2013

Status Verified

August 1, 2013

Enrollment Period

2 years

First QC Date

July 26, 2012

Last Update Submit

August 26, 2013

Conditions

Jaw, EdentulousJaw, Edentulous, Partially

Keywords

Guided Tissue RegenerationDental ImplantsMembrane, Synthetic

Outcome Measures

Primary Outcomes (1)

  • Bone volume

    Clinical effect on bone volume measured using CBCT. The volume of the newly formed bone will be evaluated by "subtraction" of the 2 cone beam CTs using digital measurements.

    Change from Baseline in bone volume at 6 months

Secondary Outcomes (2)

  • Histomorphometry

    6 months

  • Safety will be demonstrated by using VAS scale for pain measurements and if the PI will consider that any adverse event device related isn't clinically significant

    six months

Study Arms (2)

Regenecure AMCA GBR Dental membrane

EXPERIMENTAL

16 patients will undergo the guided bone regeneration procedure using the Regenecure AMCA Membrane

Device: Regenecure AMCA GBR Dental Membrane

Collagen membrane

ACTIVE COMPARATOR

16 patients will undergo the guided bone regeneration procedure using a commercially available collagen membrane

Device: Geistlich Bio-Gide® collagen membrane

Interventions

Regenecure AMCA GBR Dental MembraneDEVICE

Patients will undergo Guided Bone Regeneration (GBR) procedure using the Regenecure AMCA GBR Membrane

Regenecure AMCA GBR Dental membrane
Geistlich Bio-Gide® collagen membraneDEVICE

The Geistlich Bio-Gide® collagen membrane, a commercially available product, will be used in 10 patients.

Collagen membrane

Eligibility Criteria

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

You may qualify if:

  • Subject must have voluntarily signed the informed consent form before any study related action
  • Age: 18 to 65 with missing teeth, seeking for implant therapy.
  • Men/Women
  • In good systemic health
  • Present with no contra indication against oral surgical interventions
  • Single/ multiple tooth gap - have at least one missing tooth in the mandible or maxilla, requiring one or more dental implants.
  • The tooth at the implant site(s) must have been extracted or lost at least 6 weeks before the date of implantation.
  • Bone defect(s) must be present with a lateral dimension greater than or equal to 5 mm or less.
  • Full mouth plaque score (FMPI) lower or equal than 25%
  • Patients must be committed to the study

You may not qualify if:

  • Medical conditions requiring prolonged use of steroids
  • Use of Bisphosphonate intravenously
  • Current pregnancy or breastfeeding women
  • Alcoholism or chronically drug abuse
  • Immunocompromised patients
  • Uncontrolled Diabetes
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability.
  • Untreated inflammation
  • Mucosal diseases or oral lesions
  • History of local irradiation therapy
  • Persistent intraoral infection
  • Patients with bad oral hygiene or unmotivated for normal home care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology Hadassah and Hebrew University Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Jaw, EdentulousJaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Lior Shapira, PhD

    Haddasah Medical Center, Jerusalem Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Limor, MD

CONTACT

+ 972-2-5401013michal@regenecure.co.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2012

First Posted

August 1, 2012

Study Start

April 1, 2013

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

August 27, 2013

Record last verified: 2013-08

Locations

IL(1)