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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00454038
Other study ID # ae-01.CTIL
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received March 28, 2007
Last updated July 9, 2009
Start date June 2007
Est. completion date May 2009

Study information

Verified date January 2009
Source The Baruch Padeh Medical Center, Poriya
Contact Emad K Ailabouni, D.M.D
Phone (972)46652429
Email emadniss@netvision.net.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to investigate the efficacy of Hypro-Sorb® F, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring GBR.


Description:

Guided bone regeneration is a procedure used in dentistry for the reconstruction of osseous defects around teeth, dental implants, and prior to implant placement. The main function of the membrane barrier in GBR is to mechanically prevent the undesirable penetration of epithelial cells and fibroblasts to the bone defect area, creating a secluded space where bone regeneration may occur. Resorbable and non-resorbable membranes have been used in GBR. While non resorbable membranes require another surgical procedure for removing the membrane after the healing period, the resorbable membranes have the advantage of transmitting tissue fluids, excluding undesirable cell penetration and sparing an additional unwanted surgical procedure. The aim of this study is to investigate the efficacy of Hypro-SorbĀ® F, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring GBR.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 2009
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Cystectomy

- Segmental growing of alveolar tissue

- Lifting of the sinus bottom

- Root amputation

- Apicoectomy

- Filling of the alveolus after resections in prosthetic surgical practice

- Periimplantitis

- Maxillofacial surgery

Exclusion Criteria:

- Inside bone fractures when acrylate adhesives are applied.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
HYPRO SORB F
resorbable, double layered, collagen membrane

Locations

Country Name City State
Israel The Baruch Padeh Medical Center, Poriya Tiberias

Sponsors (1)

Lead Sponsor Collaborator
The Baruch Padeh Medical Center, Poriya

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary expected 2 years No
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