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

Description

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, before getting re-evaluated for assessing the effectiveness of the applied therapies.

Conditions

Intrabony Periodontal Defect

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Study Overview

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Study Details

Study overview

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, before getting re-evaluated for assessing the effectiveness of the applied therapies.

Rh-PDGF Versus Emdogain for Treatment of Intra-bony Defects

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

Condition
Intrabony Periodontal Defect
Intervention / Treatment

-

Contacts and Locations

Davie

Nova Southeastern University, Davie, Florida, United States, 33314

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Nova Southeastern University,

Theofilos Koutouzis, DDS, MS, STUDY_DIRECTOR, Nova Southeastern University

Study Record Dates

2025-06-30