An interventional study of Dental Implant Placement in Edentulous Alveolar Ridge, sponsored by University of Oklahoma. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Treatment
The bone grafting materials currently used in dentistry are autografts, allografts, xenografts, and alloplastic grafts. Among these different types of bone graft materials, autografts are considered to have the most predictable results due to their properties of osteogenesis, osteoinduction, and osteoconduction. However, bone autografts are rarely used due to the high morbidity associated with harvesting the bone graft from the patient with a second surgical site. Because of the increased risk to the patient with autogenous bone grafts, the current standard of care is an allograft, which is a bone graft harvested from cadaver sources such as Freeze-Dried Bone Allograft (FDBA). While allografts can only possess the qualities of osteoinduction and osteoconduction, they also have dramatically less morbidity due to the lack of a second surgical site.
Our null hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) do not show positive changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA
Our alternative hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) show similar or better results in terms of implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA.
This study will be a randomized controlled trial that will assess the changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes recorded by ISQ (Implant Stability Quotient), probing pocket depths, x-ray, and direct clinical measurements which are routinely taken as a standard of care for the dental procedures of implant placement and evaluation. A non-invasive standardizing stent with a caliper will be used for direct measurements and for bitewing radiographs for the purpose of evaluating changes in bone level. Those measurements will be taken immediately at the time of implant placement, and 4-6 months after implant placement. Calibrated examiners will evaluate implant integration. This research will be carried out by a blinded examiner who will not know the grafted material type to prevent bias.
Interventions and follow-up appointments will be conducted at the University of Oklahoma (OU), Graduate Periodontics clinic. Approximately 5 visits are anticipated for each patient. Additional appointments may be needed depending on surgical complications that need attention or intervention. Following the completion of the study, the participants will be placed on appropriate recall schedules either at the Graduate Periodontics clinic or referred to their dentist of choice. The subject's information will not be used or distributed for future research studies even if identifiers are removed.
Patients from the previous study "Alveolar Ridge Preservation with evenly distributed experimental groups of FDBA, Mineralized, and Partially Demineralized Dentin Grafts". A total of 60 patients treated with Alveolar Ridge Preservation will be eligible for implant placement.
Protocol of the experiment is as follows:
During the implant placement phase, at 4 to 6 months postoperative from the grafted sites, bone core sample will be collected using a trephine bur. Collection of sample with a trephine bur will come from area of bone being prepared for the dental implant and will be of a size that would have been removed during dental implant preparation anyway. This will occur during the same appointment as dental implant placement. The collected specimens will be labeled (name of the patient, date, and chart number) and sent to the OU Department of Oral Pathology where it will be analyzed for newly formed bone and the amount of residual bone graft material. This research will be carried out by a blinded examiner who will not know the grafted material type to prevent bias.
No population will be excluded based on race or gender. Patients under 18 years old will be excluded due to the ongoing growth potential of the alveolar bone at a younger age.
This study will be conducted at the University of Oklahoma, College of Dentistry, Department of Graduate Periodontics. Participants will be selected from patients of the College of Dentistry. Qualifying subjects will be scheduled for a screening examination appointment.
University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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Exclusion Criteria:
edentulous site grafted with FDBA in previous study.
Device: Dental Implant Placement
edentulous site grafted with partially-demineralized tooth graft in the previous study.
Device: Dental Implant Placement
edentulous site grafted with mineralized tooth graft in the previous study.
Device: Dental Implant Placement
Placement in an edentulous site that was previously bone grafted in the prior study.
Implant Stability as Measured with ISQ values of implant
Measurement of ISQ (Implant Stability Quotient) values of implant at follow-up appointments
Time frame: 6 months
Implant Failure Rate
Necessity of implant of implant removal from oral cavity
Time frame: 6 months
Probing pocket depth
measuring the depth of the periodontal pocket alongside the dental implant
Time frame: 6 months
Interproximal crestal bone level
radiographically assess bone level changes adjacent to dental implant
Time frame: 6 months
Plan to share: No — Study records will be stored in a locked room and electronic records will be stored on an encrypted server, which meets the University IT Security requirements. Patient information will be kept within the University of Oklahoma. These records will be stored indefinitely on the server and available to copying and for future studies if requested under the supervision of a designated representative and in accordance with federal regulations.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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