Continuing the nominations for the 2019-20 Castor Research Award, here is nominee #3. The Ivory Dentin Graft material study explores the safety and efficacy of using Ivory Dentin graft material for dental procedures.
Research Overview: Ivory Dentin Graft Study
GSAP is a research organization that helps pharmaceutical and medical device companies bring safe and effective products to markets worldwide.
GSAP has been conducting clinical research on the Ivory Graft v26.57. Ivory Dentin Graft is a bone graft material designed for dental procedures such as alveolar ridge preservation and augmentation, sinus elevation, and for the filling of other bony defects, in particular, to allow dental implant placement.
The materials used in these dental procedures may differ in the rate at which they integrate with the host’s bone at the graft site and the rate of resorption. The GSAP study aims to:
- Evaluate and determine the optimum time to provide a graft site solid enough for dental implant placement
- Evaluate the degree of product resorption and integration with host bone at that point in time
- Appraise safety and efficacy throughout the procedure
About the team
As Senior Clinical Trial Manager, Dr. Tal Lavi is responsible for all ongoing clinical projects. The clinical research team includes a Clinical Section Manager, a Clinical Trial Manager, and a Clinical Research Associate.
The team sets up and manages studies, prototypes study documentation, serves as a clinical advisor and also serves as liaison with local regulatory bodies for clinical studies.
Study design and methodology
The Ivory Dentin Graft study is a prospective, randomized, semi-double blind study with blind assessments comparing patients grafted with Ivory Dentin Graft (Study Arm) and patients grafted with OsteoBiol Gen Os (Control Arm) for alveolar ridge preservation following tooth extraction. A total of 44 adult patients will be enrolled and scheduled for at least one dental implant placement of mandibular premolars or molars. Patients will be randomized into two treatment groups, with an equal number of participants in the Control Arm and in the Study Arm.
GSAP’s Ivory Dentin Graft study aims to assess both the safety and efficacy of procedures using Ivory Dentin graft material. The safety endpoints will assess:
- The number of participants with treatment-related adverse events as assessed by CTCAE v4.0 through study completion, short and long-term.
- The number of participants requiring unscheduled hospital admission related to Ivory Dentin Graft through study completion, short and long-term.
- The safety and tolerability for participants following Ivory Dentin Graft implantation. To assess this, GSAP will gather data on graft site infection, poor healing of graft site, excessive bleeding, and wound dehiscence over both short and long-term.
How GSAP uses Castor
GSAP uses Castor EDC to capture, sort, and store study data. The Castor EDC system is designed to accurately implement the study protocol activities and use these protocols to generate quantitative and qualitative data sets from all enrolled subjects. The Audit Trail tracks all data uploaded through the Castor EDC system. Castor EDC enables logistical study management, such as providing or revoking rights across data collection centers and users. The platform also monitors and manages data discrepancies, flagging them to the investigator or resolving them in-house. These discrepancies, whether resolved or determined to be irresolvable by an investigator, are also stored within the Audit Trail.
With the Castor EDC platform, only users with appropriate rights can include a patient in the study. Castor EDC also enables remote data capture, automatic data cleaning, and further manual editing via a time-stamped audit trail—which is part of the validation process.
The Castor EDC system performs the randomization of GSAP study participants into the two arms of the study. Castor EDC also has a unique interface for study monitoring and automatic statistics projection with user-friendly graphics.
Stay tuned on the Castor EDC blog for more 2019-2020 Castor Research Awards nominations. We wish the nominees good luck and smart science—and encourage all researchers to share their projects for the chance to win €3000!