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

Intrabony Periodontal Defect

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

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria6

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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