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Bone Graft
Bone Graft with rhPDGF vs. Saline for Dental Implants
N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 4 months
Awards & highlights
Study Summary
This trial will compare two methods of increasing the size of the jawbone, using a resorbable barrier membrane and either a bone graft with saline or a growth factor called rhPDGF.
Who is the study for?
This trial is for adults over 18 who are patients at the UAB Dental School, need dental implants due to insufficient alveolar ridge width, and can understand the consent form. It's not for smokers, those with conditions that affect healing or oral surgery risks, non-English speakers, minors, or individuals with poor compliance risk.Check my eligibility
What is being tested?
The study compares two methods of increasing bone ridge dimensions before dental implant placement: one using a graft hydrated with saline and another using Recombinant Human Platelet-Derived Growth Factor (rhPDGF).See study design
What are the potential side effects?
Potential side effects may include discomfort at the graft site, swelling, infection risk increase around the treated area and possible allergic reactions to rhPDGF.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need dental implants for missing teeth in one part of my mouth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quantitative histomorphometric evaluation of new bone formation 4 months after GBR
Secondary outcome measures
Quantitative two- and three-dimensional radiographic comparison of dimensional changes 4 months using cone beam computed tomography (CBCT) and a virtual implant planning software, coDiagnostiX™
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Allograft particles hydrated with rhPDGFExperimental Treatment1 Intervention
Allograft particles should be hydrated with GEM21S for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane.
Group II: Allograft particles hydrated in a conventional way with saline.Active Control1 Intervention
Allograft particles should be hydrated with saline for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,584 Previous Clinical Trials
2,280,030 Total Patients Enrolled
17 Trials studying Osteoporosis
581,054 Patients Enrolled for Osteoporosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health conditions that would interfere with surgery or healing.I do not speak English.I need dental implants for missing teeth in one area of my mouth.I need dental implants for missing teeth in one part of my mouth.I have bone loss where I am missing teeth.I am under 18 years old.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Allograft particles hydrated with rhPDGF
- Group 2: Allograft particles hydrated in a conventional way with saline.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Osteoporosis Patient Testimony for trial: Trial Name: NCT04954664 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for enrollment in this trial restricted to individuals over 25 years of age?
"Compatible with the requirements for taking part in this trial, individuals must be a minimum of 18 years old and no older than 99."
Answered by AI
How can I become part of this medical research?
"This medical study seeks 44 volunteers, aged 18 to 99 years old and suffering from alopecia. Individuals must also be patients of the UAB Dental School with a need for implants in at least one quadrant of the mouth."
Answered by AI
Is this experiment presently welcoming participants?
"Indeed, the information found on clinicaltrials.gov confirms that this medical research program is actively enrolling patients; it was first posted to the website on August 11th 2021 and has since been updated lastly on August 24th 2022. A total of 44 participants are needed for participation at a single site."
Answered by AI
What is the upper bound of participants in this research endeavor?
"Affirmative. Clinicaltrials.gov attests that this study is actively recruiting for 44 patients at 1 site, which was initially posted on August 11th 2021 and revised recently on August 24th 2022."
Answered by AI
Who else is applying?
What state do they live in?
New York
Texas
Georgia
Other
How old are they?
18 - 65
What site did they apply to?
Unversity of Alabama at Birmingham, School of Dentistry
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
Hoping I would get help on implants. I really need etreatment and cannot afford it.
PatientReceived no prior treatments
I have tooth decay and truma i am seeing i can get implants. Looking for an inexpensive alternative because I'm on a fixed income.
PatientReceived 2+ prior treatments
Experience tooth decay and bone loss and can’t afford dental implants.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How soon can this be done? How hard is it to get into one of these trials?
PatientReceived no prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Unversity of Alabama at Birmingham, School of Dentistry: < 48 hours
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