CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Freeze-Dried Bone Allograft control +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05311735
NCT05311735N/ACompleted

Autogenous Mineralized and Partial Demineralized Dentin Graft Compared to Freeze Dried Bone Allograft: A Randomized Control Trial

University of Oklahoma·interventional·Posted Apr 5, 2022·Updated Jul 10, 2024

In Brief

A clinical study evaluating Freeze-Dried Bone Allograft control, Mineralized Dentin Graft, and 1 other intervention for Alveolar Bone Loss. Completed, enrolled 45 participants across 1 site.

Detailed Summary

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 its 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. Studies have shown that autogenous dentin grafts promote all three ideal mechanisms for bone regeneration. There are two methods to generate autogenous dentin grafts. One is to collect the extracted tooth and to send it to a tooth bank for the preparation process. The second is to process the extracted tooth in a clinical setting chairside, for a graft. A dentin graft can undergo different treatments such as demineralization, mineralization, and partial-demineralization. Although the autogenous dentin graft has shown positive results for bone regeneration, the comparison between partial-demineralized, mineralized autogenous dentin grafts, and freeze-dried bone grafts in the clinical setting for immediate grafting has not been studied in humans. Thus, there is a need to study the benefits of autogenous dentin partial-demineralized and mineralized grafts versus freeze-dried bone allografts regarding clinical, radiographically (bone volume and density), and efficacy results. This research addresses these areas of need.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedApr 5, 2022
Enrollment StartOct 29, 2021
Primary CompletionJun 17, 2022
Study CompletionJun 19, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.2 years ago

Interventions

Freeze-Dried Bone Allograft controlprocedure

Bone grafting to prevent alveolar ridge collapse after tooth removal

Mineralized Dentin Graftprocedure

Mineralized tooth graft used as a bone graft substitute to prevent alveolar ridge collapse after tooth removal

Partial-Demineralized Dentin Graftprocedure

Partially mineralized tooth graft used as a bone graft substitute to prevent alveolar ridge collapse after tooth removal