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Jaw, EdentulousPhase 1/2NCT01654627

Guided Bone Regeneration Using Synthetic Membrane

A Phase 1/2 study testing Regenecure AMCA GBR Dental Membrane and Geistlich Bio-Gide® collagen membrane in people with Jaw, Edentulous and Jaw, Edentulous, Partially, run by RegeneCure, Ltd. at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Jaw, Edentulous, Jaw, Edentulous, Partially
What is being tested?
Regenecure AMCA GBR Dental Membrane and Geistlich Bio-Gide® collagen membrane
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteIsrael
Study dates
Apr 2013to Jun 2015
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Michal Limor, MD contact

+ 972-2-5401013

michal@regenecure.co.il

Israel1 site, 1 recruiting

  • Department of Periodontology Hadassah and Hebrew University Medical Center

    Jerusalem

    Recruiting

Other trials in Israel

About this study

Official title: Horizontal Guided Bone Regeneration for Dental Implants Using Synthetic Membrane (Regenecures' AMCA GBR Dental Membrane) a Prospective, Randomized,Controlled Study.

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.

Being tested
Regenecure AMCA GBR Dental Membrane, Geistlich Bio-Gide® collagen membrane
Keywords
Guided Tissue Regeneration, Dental Implants, Membrane, Synthetic
Medical subject headings
Jaw, Edentulous, Jaw, Edentulous, Partially

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regenecure AMCA GBR Dental MembraneDevice

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

  • Geistlich Bio-Gide® collagen membraneDevice

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

Study groups in NCT01654627
Study groupRoleWhat they receive
Regenecure AMCA GBR Dental membraneExperimental16 patients will undergo the guided bone regeneration procedure using the Regenecure AMCA Membrane
Receives: Device: Regenecure AMCA GBR Dental Membrane
Collagen membraneActive comparator16 patients will undergo the guided bone regeneration procedure using a commercially available collagen membrane
Receives: Device: Geistlich Bio-Gide® collagen membrane

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from Baseline in bone volume at 6 months

Secondary outcomes (2)

  1. Histomorphometry

    Specimens will be prepared for histological staining (H\&E and Masson's trichrome stain). The stained samples will be evaluated for new bone, residual bone graft, marrow spaces and vascularity.

    Measured: 6 months

  2. 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

    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

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2012 (estimated)
  2. Study startApr 2013
  3. Primary completionApr 2015 (estimated)
  4. Study completionJun 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01654627
Sponsor's protocol ID
RGD001
Status last verified
Aug 2013
First submitted
26 Jul 2012
Last updated
27 Aug 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Regenecure AMCA GBR Dental Membrane and Geistlich Bio-Gide® collagen membrane in people with Jaw, Edentulous and Jaw, Edentulous, Partially, run by RegeneCure, Ltd. at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michal Limor, MD (+ 972-2-5401013, michal@regenecure.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone volume (time frame: Change from Baseline in bone volume at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01654627.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2013.

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