RecruitingPhase 1Phase 2NCT05442034

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

Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects


Sponsor

Nova Southeastern University

Enrollment

36 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Treatment of intra-bony defects is challenging and requires extensive knowledge of the etiology, anatomy, occlusion, and available biomaterials that can be used to treat this kind of defects. Patients who received scaling and root planing at the college of dental medicine due to periodontal disease, will be screened for inclusion. Only subjects who showed persistent deep probing depth associated with an intrabony defect will be included and will be randomly allocated to one of two treatment groups. One group will be treated using recombinant human platelet derived growth factor (GEM-21) (test) added to allogenic bone graft, second group will be treated using enamel matrix derivatives (EMD) (control) with allograft. Both groups will be treated using the same surgical protocol. Patients will be followed up for a period of 6 months and 12 months, before getting re-evaluated for assessing the effectiveness of the applied therapies.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments applied to pockets between the teeth and gum that are caused by periodontitis (gum disease with bone loss): one uses a growth factor protein called rh-PDGF, and the other uses enamel matrix proteins (EMD, also known as Emdogain). Both are injected into the bone defect during gum surgery to help regenerate lost bone and gum tissue. You may be eligible if: - You are 18 or older with no serious medical conditions - You recently completed scaling and root planing for gum disease - You have a deep pocket (6 mm or more) with at least 3 to 6 mm of bone loss - Your overall oral hygiene (plaque and bleeding scores) is below 20% - You are available for 6-month follow-up You may NOT be eligible if: - You are pregnant or planning to become pregnant during the study - You smoke more than 10 cigarettes a day - You have uncontrolled diabetes (HbA1c above 7.5) - You take medications that affect the gums (such as phenytoin or alendronate) - There is an abscess or infection at the root of the treated tooth Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALgrowth factors to help in regeneration

regenerative therapy


Locations(1)

Nova Southeastern University

Davie, Florida, United States

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NCT05442034


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