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RecruitingAccepts healthy volunteersPhase 1/Phase 2

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

Nova Southeastern University · NCT05442034

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1, Phase 2
Target enrollment
36
US sites recruiting
1
Study start
January 1, 2023
Record last updated
April 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: growth factors to help in regeneration

Conditions: Intrabony Periodontal Defect

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Nova Southeastern University

    Davie, FL 33314

    Site contact: Arsalan Danesh, DDS · 561-212-6377 · ad2900@mynsu.nova.edu

Study contacts (from the official record)

  • Neshatafarin Manouchehri, D.D.S · 7342494806 · nm1859@mynsu.nova.edu
  • Theofilos Koutouzis, DDS, MS · 954-262-1742 · tkoutouzis@nova.edu
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Rh-PDGF vs EMD for Treatment of Intra-bony Defects (NCT05442034) | Bored Studies