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

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllNova Southeastern University
NCT05442034 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 th

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📋 Eligibility rules (as published)
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
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What it tests

  • growth factors to help in regeneration
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Where

1 site
Nova Southeastern University
Davie, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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