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Growth Factor
Growth Factors vs EMD for Periodontal Defects
Phase 1 & 2
Recruiting
Research Sponsored by Nova Southeastern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age is 18 years old and older
Non-contained intra-bony defects (1-wall, 2-wall intra-bony defects)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing whether adding growth factor to bone graft helps treat periodontal disease better than using enamel matrix derivatives.
Who is the study for?
This trial is for adults over 18 who've had scaling and root planing for periodontal disease, with deep pockets next to bone defects in their teeth. They must be able to come back for a 6-month check-up and not have serious health issues or habits like heavy smoking that could affect the results.Check my eligibility
What is being tested?
The study compares two treatments on people with gum disease: one group gets human growth factor (Rh-PDGF) added to a bone graft, while the other gets enamel matrix derivatives (EMD) with a bone graft. Both groups follow the same surgery steps and are checked after six months.See study design
What are the potential side effects?
Possible side effects aren't detailed here, but generally, treatments involving growth factors can cause discomfort at the injection site, swelling, or infection. The specific side effects will depend on individual reactions to Rh-PDGF or EMD.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have bone defects that are not enclosed.
Select...
I recently had a deep cleaning for gum disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Attachment Changes
Side effects data
From 2007 Phase 3 trial • 330 Patients • NCT0003581562%
Depression
53%
Site reactions
33%
Respiratory failure
14%
Change in visual acuity
13%
Hypoglycemia
13%
Headache
11%
Thrombotic events
8%
Hepatotoxicity
6%
Abnormal blood chemistries (other than liver)
100%
80%
60%
40%
20%
0%
Study treatment Arm
IGF-1
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograftExperimental Treatment1 Intervention
recombinant human platelet derived growth factor is a protein that is found in blood serum. It helps to recruit stem cells into the area to aid in cell differentiation and proliferation. When added to mineralized bone allograft, it stimulates the angiogenesis in the area, and this in turn may increase the outcomes of regeneration.
Group II: Enamel matrix derivatives (EMD) in combination with bone allograft.Active Control1 Intervention
Enamel matrix derivatives are natural proteins that are produced in the developing dental follicle. It has been available for decades and has been proved to help in regeneration of intrabony defects when applied into the root surface. When combined with bone allograft, it results in regeneration of intrabony defects.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Nova Southeastern UniversityLead Sponsor
89 Previous Clinical Trials
11,605 Total Patients Enrolled
Theofilos Koutouzis, DDS, MSStudy DirectorNova Southeastern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have both single and multiple rooted teeth in my upper or lower jaw.I have a root tip infection in the area being tested.I am 18 years old or older.I do not have any major health issues.I am willing to follow the study's rules and procedures.I have single or multiple rooted teeth in my upper or lower jaw.I have bone defects that are not enclosed.I recently had a deep cleaning for gum disease.I am not pregnant nor planning to become pregnant during the study.I haven't taken medications like Phenytoin or Alendronate in the last 6 months.My diabetes is not under control (HbA1c >7.5).
Research Study Groups:
This trial has the following groups:- Group 1: Enamel matrix derivatives (EMD) in combination with bone allograft.
- Group 2: recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants being welcomed into this experiment?
"The information held on clinicaltrials.gov indicates that this research venture is not currently enrolling participants, despite being posted in October of 2022 and most recently updated in September of the same year. Nevertheless, 9 other trials are still recruiting patients at present time."
Answered by AI
Who else is applying?
What site did they apply to?
Nova Southeastern University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
Looking for solutions for periodontal disease.
PatientReceived 2+ prior treatments
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