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Bone Graft
Putty Grafts 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
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Alveolar ridge height
Alveolar ridge width
Buccal soft tissue thickness
Secondary study objectives
Percentage of vital bone present
Awards & Highlights
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.
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
345 Previous Clinical Trials
77,559 Total Patients Enrolled
BioHorizons, Inc.Industry Sponsor
16 Previous Clinical Trials
472 Total Patients Enrolled
Bindu Dukka, BDS,MSD,MPHPrincipal InvestigatorDirector, Graduate Periodontics, University of Louisville
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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.
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