MedTrace Logo

Mineralized and Partial Demineralized Dentin Graft Compared to FDBA

NCT05311735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-07-10

No results posted yet for this study

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.

Conditions

  • Alveolar Bone Loss

Interventions

PROCEDURE

Freeze-Dried Bone Allograft control

Bone grafting to prevent alveolar ridge collapse after tooth removal

PROCEDURE

Mineralized Dentin Graft

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

PROCEDURE

Partial-Demineralized Dentin Graft

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

Sponsors & Collaborators

  • Delta Dental Foundation

    collaborator OTHER

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Robin Henderson, DMD MS · University of Oklahoma College of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-29
Primary Completion
2022-06-17
Completion
2024-06-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05311735 on ClinicalTrials.gov