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

NCT05442034 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2022-217-NSU
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Periodontal regeneration; Inta-bony defects; Enamel matrix derivatives

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment Changes

  Change in gingival recession and pocket probing depth

  12 months

Study Arms (2)

recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft

EXPERIMENTAL

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.

Biological: growth factors to help in regeneration

Enamel matrix derivatives (EMD) in combination with bone allograft.

ACTIVE COMPARATOR

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.

Biological: growth factors to help in regeneration

Interventions

growth factors to help in regeneration BIOLOGICAL

regenerative therapy

Enamel matrix derivatives (EMD) in combination with bone allograft.; recombinant human platelet derived growth factor (rh-PDGF) in combination with bone allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead

Study Sites (1)

Nova Southeastern University

Davie, Florida, 33314, United States

RECRUITING

MeSH Terms

Interventions

Regeneration

Intervention Hierarchy (Ancestors)

Biological Phenomena

Study Officials

• Theofilos Koutouzis, DDS, MS

  Nova Southeastern University

  STUDY DIRECTOR

Central Study Contacts

Neshatafarin Manouchehri, D.D.S

CONTACT

7342494806; nm1859@mynsu.nova.edu

Theofilos Koutouzis, DDS, MS

CONTACT

954-262-1742; tkoutouzis@nova.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which biologic agent (rh-PDGF or EMD) is being used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Test group will receive rh-PDGF in combination with bone allograft Control group will receive EMD in combination with bone allograft.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)