Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT05442034

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

Led by Nova Southeastern University · Updated on 2026-04-16

36

Participants Needed

1

Research Sites

234 weeks

Total Duration

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AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nova Southeastern University

Davie, Florida, United States, 33314

Actively Recruiting

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Research Team

N

Neshatafarin Manouchehri, D.D.S

CONTACT

T

Theofilos Koutouzis, DDS, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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