RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-01-01
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05442034

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age is 18 years old and older
  2. * Absence of relevant medical conditions
  3. * Availability for 6-month follow-up
  4. * Subjects who recently have received scaling and root planing due to periodontal disease
  5. * Single-rooted and multi-rooted teeth in either the maxilla or the mandible.
  6. * Presence of interdental periodontal pocket with PD ≥ 6 mm associated to an intra-bony component ranged from 3 to 6 mm.
  7. * Non-contained intra-bony defects (1-wall, 2-wall intra-bony defects)
  8. * Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \<20% at surgery
  1. * Female patients who are pregnant or planning to be pregnant during the period of the study
  2. * Heavy smokers (\>10 cigarettes a day)
  3. * Subjects not willing to comply to the study protocol
  4. * Patients with uncontrolled diabetes (HbA1c \>7.5)
  5. * Patients receiving medications that may affect periodontal status in the previous 6 months (e.g., Phenytoin, Alendronate)
  6. * Periapical lesion in the tested sites

Contacts and Locations

Study Contact

Arsalan Danesh, D.D.S
CONTACT
5612126377
ad2900@mynsu.nova.edu
Theofilos Koutouzis, DDS, MS
CONTACT
954-262-1742
tkoutouzis@nova.edu

Principal Investigator

Theofilos Koutouzis, DDS, MS
STUDY_DIRECTOR
Nova Southeastern University

Study Locations (Sites)

Nova Southeastern University
Davie, Florida, 33314
United States

Collaborators and Investigators

Sponsor: Nova Southeastern University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Intrabony Periodontal Defect