Procedures to repair the jaws because of traumatic injury, resecting cancer treatments, or gum disease (periodontal disease) most often utilize a thin film or membrane to help shape and guide the rebuilding of the jaw. More than half a million such procedures are performed annually in the U.S. but it has been estimated that a fourth of them fail for reasons related to the membrane. The significant issue directly being addressed by this project is the unacceptably high rate of membrane failure seen in these regenerative procedures, specifically ridge augmentation prior to implant placement. These failures should not occur as they put the patient at significant risk of deep infection with complications, and they necessitate a second attempt at the regenerative procedure, all of which are burdensome to the patient, the practitioner, our national collective health, and our health care system, as these procedures are relatively commonplace.
The proposed pilot clinical trial will enroll 20 subjects from the UAB School of Dentistry scheduled for GBR to be followed by placement of dental implants. Two treatment conditions will be compared for clinical outcome superiority using an open-label format. Each participant will receive a commercial bone graft material with the test membrane placed superiorly over the graft material to augment the height and/or width of the existing mandibular ridge. Five subjects (Group 2) will be in a cohort receiving a second bone graft at a contralateral treatment site that will receive a commercial collagen membrane allowing matched pairs comparisons.
Safety will be assessed in all subjects by clinical observation at 1 wk, 2 wk, 6 wk, and 6 month clinic visits, and by analysis of radiographs taken at 6 weeks followed by a CT scan 6 months post-placement, where maintenance of the membrane with gingival closure and lack of radiographic evidence of ridge resorption are the primary safety outcomes (Aim 1). Efficacy will be assessed in matched pairs analysis (Group 2 cohort) by standardized measurements of new bone height determined from 6 month CT scans with Amira software 3D segmentation where the null hypothesis of no difference between the two conditions will be tested (Aim2).
Chitosan has been used in oral wound healing for many years and, for the first time, we have developed it into a sheer, strong, pliable, biocompatible membrane with what appear to be excellent handling characteristics. The surgical indications of use for this new material are myriad and provide additional significance to the project in terms of US health care impact.
Click on the link below to view the project plan as originally proposed.