Skip to main content
Clinical Trials/NCT03924336
NCT03924336
Completed
Not Applicable

Evaluation of CAL Gain Following Treatment of Intraosseous Defects With A-PRF+ Compared to Open Flap Debridement in Patients With Stage III Periodontitis: A Randomized Clinical Trial

Cairo University1 site in 1 country22 target enrollmentSeptember 30, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intrabony Periodontal Defect
Sponsor
Cairo University
Enrollment
22
Locations
1
Primary Endpoint
Clinical Attachment Level (CAL) gain
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

To assess the effectiveness of advanced PRF+ as compared to open flap debridement in treatment of periodontal intraosseous defects in stage III periodontitis patients.

Detailed Description

The application of platelet concentrates characterized by high concentrations of platelets and growth factors have been applied and investigated as possible periodontal regenerative therapy. The application of platelet rich fibrin in management of intraosseous and furcation defects produce more favorable outcome compared to open flap debridement. A-PRF+ represents the latest generation of platelet concentrates that could provide sustained and increased release of growth factors and could serve as an autologous cost-effective membrane in periodontal tissue regeneration procedures

Registry
clinicaltrials.gov
Start Date
September 30, 2019
End Date
September 7, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yasser Ali Abdu

Principal Investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intraosseous defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
  • Defect not extending to a root furcation area
  • Non-smokers.
  • No history of intake of medications affecting the periodontium in the previous 6 months.
  • Able to sign an informed consent form.
  • Patients age between 18 and 60 years old.
  • Patients who are cooperative, motivated, and hygiene conscious.
  • Systemically free according to Cornell Medical Index (Broadbent, 1951).

Exclusion Criteria

  • Pregnancy or breast feeding
  • The presence of an orthodontic appliance
  • Teeth mobility greater than grade I

Outcomes

Primary Outcomes

Clinical Attachment Level (CAL) gain

Time Frame: Change from Baseline Clinical Attachment Level (CAL) at 9 months

Clinical Attachment Level (CAL) will be measured from the cemento enamel junction (CEJ) to the bottom of the gingival sulcus/periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth

Secondary Outcomes

  • Probing Depth (PD)(Probing Depth will be measured at base line,3,6, and 9 months postoperative)
  • Radiographic defect fill(Radiographic defect fill will be measured at 6,9,months)
  • Gingival Recession Depth (RD)(Gingival Recession Depth will be measured at base line,3,6, and 9 months postoperative)

Study Sites (1)

Loading locations...

Similar Trials