← Back to Search

Growth Factor

Growth Factors 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

Subjects who recently have received scaling and root planing due to periodontal disease

Presence of interdental periodontal pocket with PD ≥ 6 mm associated to an intra-bony component ranged from 3 to 6 mm.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up6 months

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is testing whether adding growth factor to bone graft helps treat periodontal disease better than using enamel matrix derivatives.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You do not have any medical conditions that could interfere with the study.

Select...

You have teeth in either the upper or lower jaw with one or more roots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 • NCT00035815

62%

Depression

53%

Site reactions

33%

Respiratory failure

14%

Change in visual acuity

13%

Headache

13%

Hypoglycemia

11%

Thrombotic events

Hepatotoxicity

Abnormal blood chemistries (other than liver)

100%

80%

60%

40%

20%

Study treatment Arm

IGF-1

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 6Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Nova Southeastern UniversityLead Sponsor

86 Previous Clinical Trials

11,414 Total Patients Enrolled

Theofilos Koutouzis, DDS, MSStudy DirectorNova Southeastern University

Media Library

Recombinant human platelet derived growth factor (GEM-21) (Growth Factor) Clinical Trial Eligibility Overview. Trial Name: NCT05442034 — Phase 1 & 2

Periodontal Defects Research Study Groups: Enamel matrix derivatives (EMD) in combination with bone allograft., recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft

Periodontal Defects Clinical Trial 2023: Recombinant human platelet derived growth factor (GEM-21) Highlights & Side Effects. Trial Name: NCT05442034 — Phase 1 & 2

Recombinant human platelet derived growth factor (GEM-21) (Growth Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05442034 — Phase 1 & 2

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

Recent research and studies

clinicaltrials.govStudy

Rh-PDGF vs EMD for Treatment of Intra-bony Defects

Arsalan Danesh 2023. "Rh-PDGF vs EMD for Treatment of Intra-bony Defects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05442034.