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Guided Bone Regeneration Using Synthetic Membrane

NCT ID: NCT01654627

Last Updated: 2013-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Jaw, Edentulous Jaw, Edentulous, Partially

Keywords

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Guided Tissue Regeneration Dental Implants Membrane, Synthetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Regenecure AMCA GBR Dental membrane

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

Group Type EXPERIMENTAL

Regenecure AMCA GBR Dental Membrane

Intervention Type DEVICE

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

Collagen membrane

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

Group Type ACTIVE_COMPARATOR

Geistlich Bio-Gide® collagen membrane

Intervention Type DEVICE

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

Interventions

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Regenecure AMCA GBR Dental Membrane

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

Intervention Type DEVICE

Geistlich Bio-Gide® collagen membrane

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RegeneCure, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lior Shapira, PhD

Role: PRINCIPAL_INVESTIGATOR

Haddasah Medical Center, Jerusalem Israel

Locations

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Department of Periodontology Hadassah and Hebrew University Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Michal Limor, MD

Role: CONTACT

Phone: + 972-2-5401013

Email: [email protected]

Other Identifiers

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RGD001

Identifier Type: -

Identifier Source: org_study_id