Viewing Study NCT03433066


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Study NCT ID: NCT03433066
Status: UNKNOWN
Last Update Posted: 2019-02-05
First Post: 2018-02-08
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Advanced Platelet Rich Fibrin in Periodontal Angular Defects
Sponsor: Alexandria University
Organization:

Study Overview

Official Title: Evaluation of Advanced Platelet-rich Fibrin in Management of Periodontal Intrabony Defects
Status: UNKNOWN
Status Verified Date: 2019-02
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of this study is to clinically and radiographically evaluate the efficacy of advanced platelet-rich fibrin (A-PRF) when used with biphasic alloplast in the management of intrabony defects in patients with moderate to severe chronic periodontitis.
Detailed Description: Biphasic alloplasts have been successfully used in management of intrabony defects. Advanced platelet-rich fibrin is believed to contain higher amount of growth factors and white blood cells than the well known PRF. Although there are some studies on the use of PRF in the treatment of intrabony defects, to date none of them evaluate the effect of the A-PRF. Therefore, a randomized controlled clinical trial was conducted to compare the healing of intrabony defects treated with A-PRF/biphasic alloplast combination and to those obtained with biphasic alloplast mixed with saline. Using a parallel arm design, 22 intrabony defects were randomly treated with either biphasic alloplast mixed with saline (control group) or with A-PRF/ biphasic alloplast combination (test group). The following clinical parameters were recorded at baseline, three and six months postoperatively : plaque index (PI), modified gingival index (MGI), probing depth (PD), clinical attachment level (CAL), while these radiographic measurements were recorded at baseline and six months postoperatively: bone fill and bone density.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: