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

2022-217-NSU

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, before getting re-evaluated for assessing the effectiveness of the applied therapies.

2023-01-01

2025-06-30

2025-06-30

Recruiting

Early phase I

36

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Test group will receive rh-PDGF in combination with bone allograft Control group will receive EMD in combination with bone allograft.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Participants will not know which biologic agent (rh-PDGF or EMD) is being used.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

2023-08-15