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Platelet-Rich Fibrin and Anorganic Bovine Bone vs Collagen Membrane and Anorganic Bovine Bone in Intrabony Defects

NCT03715374 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-11-20

No results posted yet for this study

Summary

The primary outcome of periodontal reconstructive therapy is to regenerate all tissues of the periodontium including a functional periodontal ligament, alveolar bone and cementum. A number of treatment modalities including the use of bone grafts, guided tissue regeneration (GTR), and the addition of biological agents have been used with large heterogeneity in the clinical and histological outcomes. The rationale of using a filling material when treating unfavorable and large intrabony defects (IBDs) with membranes or biological agents consists of sustaining the overlying soft tissues in the presence of a non-contained defect's architecture, at the same time enhancing the stability of coagulum; and facilitating the proliferation of mesenchymal progenitor cells. Among bone grafts available, anorganic bone bone (ABB) have been widely used in periodontics for the treatment of IBDs In recent years, the increasing understanding of the role of growth factors (GFs) in the wound healing process suggested the use of these biological agents in the regenerative treatment of periodontal bony defects. Noninferiority trials are designed to demonstrate that the effect of a new treatment is adequately similar to an active control by more than a specified margin The aim of this study is to verify if the combined use of PRF (Platelet Rich Fibrin) and ABB in the management of IBDs may be a treatment modality that is clinically "not inferior" compared to the membrane + ABB one, since the combined periodontal regenerative technique has been already tested in literature as a "gold standard" periodontal regenerative technique.

Conditions

  • Periodontal Attachment Loss
  • Periodontal Bone Loss
  • Periodontal Diseases

Interventions

PROCEDURE

Periodontal Surgery with PRF+ABB

Patients will be treated by periodontal surgical flaps with the addition of PRF+ Anorganic Bovine Bone filling material

PROCEDURE

Periodontal Surgery with Collagen Membrane +ABB

Patients will be treated by periodontal surgical flaps with the addition of Collagen Membrane + Anorganic Bovine Bone filling material

Sponsors & Collaborators

  • G. d'Annunzio University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2018-11-16
Completion
2018-12-12

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715374 on ClinicalTrials.gov