Comparing two treatments for intra-bony periodontal defects
Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects
This study is testing whether a new treatment using growth factors works better than a standard treatment for helping adults with deep gum pockets heal and regain healthy gum tissue.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nova Southeastern University Academic / other |
| Locations | 1 site (Davie, Florida) |
| Trial ID | NCT05442034 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of recombinant human platelet-derived growth factor (GEM-21) versus enamel matrix derivatives (EMD) in treating intra-bony periodontal defects. Patients aged 18 and older who have persistent deep probing depths after scaling and root planing will be randomly assigned to receive one of the two treatments combined with an allogenic bone graft. The study will follow participants for six months to assess clinical attachment gain, pocket depth reduction, and radiographic bone height improvement. The trial seeks to enhance understanding of periodontal regeneration techniques and their outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with specific intra-bony defects and a history of periodontal disease.
Not a fit: Patients with uncontrolled diabetes, heavy smokers, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with intra-bony periodontal defects, enhancing their periodontal health.
How similar studies have performed: Previous studies have shown promising results with similar regenerative approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age is 18 years old and older * Absence of relevant medical conditions * Availability for 6-month follow-up * Subjects who recently have received scaling and root planing due to periodontal disease * Single-rooted and multi-rooted teeth in either the maxilla or the mandible. * Presence of interdental periodontal pocket with PD ≥ 6 mm associated to an intra-bony component ranged from 3 to 6 mm. * Non-contained intra-bony defects (1-wall, 2-wall intra-bony defects) * Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \<20% at surgery Exclusion Criteria: * Female patients who are pregnant or planning to be pregnant during the period of the study * Heavy smokers (\>10 cigarettes a day) * Subjects not willing to comply to the study protocol * Patients with uncontrolled diabetes (HbA1c \>7.5) * Patients receiving medications that may affect periodontal status in the previous 6 months (e.g., Phenytoin, Alendronate) * Periapical lesion in the tested sites
Where this trial is running
Davie, Florida
- Nova Southeastern University — Davie, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Neshatafarin Manouchehri, D.D.S
- Email: nm1859@mynsu.nova.edu
- Phone: 7342494806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.