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Bone Graft
demineralized and mineralized combination putty bone allograft for Alveolar Bone Loss
Phase 4
Recruiting
Led By Bindu Dukka, BDS,MSD,MPH
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trial will compare two types of materials used in socket preservation procedures after four months.
Who is the study for?
This trial is for healthy adults over 18 who need a non-molar tooth replaced with an implant and can consent to the study. It's not for those who've had chemotherapy in the last year, are pregnant, allergic to materials used, have jaw bone issues or severe systemic diseases, took certain bone treatments, or need long-term NSAIDs/steroids.Check my eligibility
What is being tested?
The study compares two types of grafts used in socket preservation after tooth extraction: a putty allograft made from processed human bone and a synthetic graft made from calcium phosphosilicate. The outcomes will be assessed clinically and microscopically after 4 months.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include infection at the site of surgery, inflammation or pain around the area where the material is placed, allergic reactions to graft materials or membranes used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alveolar ridge height
Alveolar ridge width
Buccal soft tissue thickness
Secondary outcome measures
Percentage of vital bone present
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: demineralized and mineralized combination putty bone allograftExperimental Treatment1 Intervention
Fifteen test patients will receive an intrasocket demineralized and mineralized combination putty allograft (MinerOss Putty, BioHorizons) with a regenerative tissue matrix membrane (AlloDerm GBR, BioHorizons) following tooth extraction.
Group II: calcium phosphosilicate putty alloplast graftActive Control1 Intervention
The positive control group of fifteen patients will receive an intrasocket synthetic resorbable calcium phosphosilicate putty alloplast graft (NovaBone, Osteogenics) covered with a regenerative tissue matrix membrane (AlloDerm GBR, BioHorizons) following tooth extraction.
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Who is running the clinical trial?
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,954 Total Patients Enrolled
1 Trials studying Alveolar Bone Loss
15 Patients Enrolled for Alveolar Bone Loss
BioHorizons, Inc.Industry Sponsor
16 Previous Clinical Trials
533 Total Patients Enrolled
1 Trials studying Alveolar Bone Loss
25 Patients Enrolled for Alveolar Bone Loss
Bindu Dukka, BDS,MSD,MPHPrincipal InvestigatorDirector, Graduate Periodontics, University of Louisville
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to any of the materials or medications used in the study.You need to have a single tooth removed and replaced with a dental implant.You have a severe illness that affects your whole body, or a disease that significantly affects your gums and teeth.You have had radiation therapy in the past for your head and neck.You are taking nonsteroidal anti-inflammatory drugs or steroids for a prolonged period of time.
Research Study Groups:
This trial has the following groups:- Group 1: demineralized and mineralized combination putty bone allograft
- Group 2: calcium phosphosilicate putty alloplast graft
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being invited to participate in this research initiative?
"Affirmative. According to the information hosted on clinicaltrials.gov, this medical investigation started recruiting patients since October 6th 2022 and is still actively seeking participants. The goal is to collect data from 30 people at 1 specific site."
Answered by AI
Are there vacancies in this clinical research program available to participants?
"Affirmative. On clinicaltrials.gov, it is evident that the study has opened recruitment for participants since October 6th 2022 and was last updated on November 8th of this same year. The trial requires 30 patients to be recruited from one medical center."
Answered by AI
What sort of adverse effects might patients experience when using demineralized and mineralized combination putty bone allografts?
"With the Phase 4 trial data in hand, it is safe to say that demineralized and mineralized combination putty bone allograft has a safety rating of 3 on our scale."
Answered by AI
Who else is applying?
What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Recent research and studies
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