Recruiting
Phase 1
Phase 2

Rh-PDGF vs EMD

Sponsor:

Nova Southeastern University

Code:

NCT05442034

Conditions

Intrabony Periodontal Defect

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

growth factors to help in regeneration

Study Details

Brief 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 and 12 months, before getting re-evaluated for assessing the effectiveness of the applied therapies.

Conditions

Intrabony Periodontal Defect

Study ID

NCT05442034

Start date

Jan 1, 2023

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

growth factors to help in regeneration

regenerative therapy

Primary outcome measure

  • Clinical Attachment Changes [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Neshatafarin Manouchehri, D.D.S

7342494806nm1859@mynsu.nova.edu

Theofilos Koutouzis, DDS, MS

954-262-1742tkoutouzis@nova.edu

Locations

Nova Southeastern University

Recruiting

Davie, Florida, United States, 33314

Contacts

Arsalan Danesh, DDS

561-212-6377ad2900@mynsu.nova.edu

Cristina Garcia Godoy, DDS

954-262-7388cgarciag@nova.edu

More Information

Sponsor

Nova Southeastern University

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Periodontal regeneration
  • Inta-bony defects
  • Enamel matrix derivatives

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nova Southeastern University on 2026-04-16.