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Bone Graft
Dentin Graft vs Bone Allograft for Alveolar Bone Loss
N/A
Recruiting
Led By Robin Henderson, DMD MS
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Alveolar sockets with intact four-wall architecture
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post guided bone regeneration procedure
Awards & highlights
Study Summary
This trial will compare the effects of autogenous dentin partial-demineralized and mineralized grafts versus freeze-dried bone allografts on bone regeneration.
Who is the study for?
This trial is for adults over 18 with teeth needing extraction and intact alveolar sockets. Participants must understand and agree to the study's requirements. It excludes pregnant or lactating women, those with active gum disease, root-filled or infected teeth, heavy smokers, uncontrolled diseases, past head/neck radiation therapy, or bisphosphonate use.Check my eligibility
What is being tested?
The study compares three bone graft materials in dental surgery: Mineralized Dentin Graft (MDG), Partial-Demineralized Dentin Graft (PDDG), and Freeze-Dried Bone Allograft (FDBA). The goal is to see which material best promotes bone regeneration clinically and on X-rays.See study design
What are the potential side effects?
Potential side effects may include discomfort at the graft site, swelling, infection risk increase due to surgery, allergic reactions to graft materials if any existent allergies are unknown prior to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tooth sockets are fully intact.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post guided bone regeneration procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post guided bone regeneration procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical-radiographical differences in terms of bone density between dentin tooth grafts and FDBA.
Clinical-radiographical differences in terms of bone volume between dentin tooth grafts and FDBA.
Secondary outcome measures
Surgical cost saving measurement utilizing dentin tooth graft and FDBA.
Surgical efficiency utilizing dentin tooth graft and FDBA.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Partial-Demineralized Dentin GraftExperimental Treatment1 Intervention
-Test group II (partial-demineralized tooth graft): extracted teeth will be undergone to partial-demineralized process, according to the manufacture's guidelines. Procedures will be done in a specialized equipment for tooth graft preparation (Smart Dentin Grinder® (SDG) (KometaBio), and then sites will be grafted. Remaining graft will be stored appropriately for future grafting in the same patient (according to the guidelines).
Group II: Mineralized Dentin GraftExperimental Treatment1 Intervention
-Test group I (mineralized tooth graft): extracted teeth will undergo the mineralization process according to the manufacture's guidelines. Procedure will be done in a specialized equipment for tooth graft preparation (Smart Dentin Grinder® (SDG) (KometaBio), and then sites will be grafted. Remaining graft will be stored appropriately for future grafting in the same patient (according to the guidelines)
Group III: Freeze-Dried Bone Allograft ControlExperimental Treatment1 Intervention
-Control group (FDBA): extracted teeth will be discarded and sites will be grafted with FDBA.
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,568 Total Patients Enrolled
Delta Dental FoundationOTHER
7 Previous Clinical Trials
1,390 Total Patients Enrolled
1 Trials studying Alveolar Bone Loss
20 Patients Enrolled for Alveolar Bone Loss
Robin Henderson, DMD MSPrincipal InvestigatorUniversity of Oklahoma College of Dentistry
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need at least one tooth extracted.I am 18 years old or older.I am currently using or have used IV bisphosphonates.I have an acute infection in a tooth that needs to be extracted.I have had a root canal treatment.I have active gum disease.I have a tooth infection at the root.I have had radiotherapy on my head or neck in the last 5 years.My tooth sockets are fully intact.I have a disease that is not currently under control.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are actively involved in this investigation?
"Affirmative. The clinical trial is seeking participants, as indicated by the information on clinicaltrials.gov which was last updated April 11th 2022, having initially been posted October 29th 2021. This experiment requires 45 subjects to be enrolled at one medical site."
Answered by AI
Is there still the possibility of enrolling in this clinical trial?
"As indicated on clinicaltrials.gov, the enrollment period for this trial has been open since October 29th 2021 and was last updated on April 11th 2022."
Answered by AI
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