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Guided Bone Regeneration Using Synthetic Membrane

Primary Purpose

Jaw, Edentulous, Jaw, Edentulous, Partially

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Regenecure AMCA GBR Dental Membrane

Geistlich Bio-Gide® collagen membrane

About this trial

This is an interventional treatment trial for Jaw, Edentulous focused on measuring Guided Tissue Regeneration, Dental Implants, Membrane, Synthetic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Periodontology Hadassah and Hebrew University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regenecure AMCA GBR Dental membrane

Collagen membrane

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT01654627

First Posted

July 26, 2012

Last Updated

August 26, 2013

Sponsor

RegeneCure, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01654627

Brief Title

Guided Bone Regeneration Using Synthetic Membrane

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Unknown status

Study Start Date

April 2013 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RegeneCure, Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Jaw, Edentulous, Jaw, Edentulous, Partially

Keywords

Guided Tissue Regeneration, Dental Implants, Membrane, Synthetic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Regenecure AMCA GBR Dental membrane

Arm Type

Experimental

Arm Description

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

Arm Title

Collagen membrane

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Regenecure AMCA GBR Dental Membrane

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Geistlich Bio-Gide® collagen membrane

Intervention Description

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

Primary Outcome Measure Information:

Title

Bone volume

Description

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.

Time Frame

Change from Baseline in bone volume at 6 months

Secondary Outcome Measure Information:

Title

Histomorphometry

Description

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.

Time Frame

6 months

Title

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

Description

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

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michal Limor, MD

Phone

+ 972-2-5401013

michal@regenecure.co.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lior Shapira, PhD

Organizational Affiliation

Haddasah Medical Center, Jerusalem Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Periodontology Hadassah and Hebrew University Medical Center

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

12. IPD Sharing Statement

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Guided Bone Regeneration Using Synthetic Membrane

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