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

Conditions

• Intrabony Periodontal Defect

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• growth factors to help in regeneration — BIOLOGICAL
  regenerative therapy

Study Details

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.

Key Dates

Start date

Jan 1, 2023

Status verified

Apr 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft
  recombinant human platelet derived growth factor is a protein that is found in blood serum. It helps to recruit stem cells into the area to aid in cell differentiation and proliferation. When added to mineralized bone allograft, it stimulates the angiogenesis in the area, and this in turn may increase the outcomes of regeneration.
• Active Comparator: Enamel matrix derivatives (EMD) in combination with bone allograft.
  Enamel matrix derivatives are natural proteins that are produced in the developing dental follicle. It has been available for decades and has been proved to help in regeneration of intrabony defects when applied into the root surface. When combined with bone allograft, it results in regeneration of intrabony defects.

Primary Outcome Measure

Clinical Attachment Changes [ Time Frame: 12 months ]

Central Contacts

• Neshatafarin Manouchehri, D.D.S
  7342494806
  [email protected]
• Theofilos Koutouzis, DDS, MS
  954-262-1742
  [email protected]

Locations (1)

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