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Clinical Trials/NCT03900013
NCT03900013
Unknown
N/A

Clinical and Radiographic Evaluation of Injectable PRF With Demineralized Freeze-Dried Bone Allograft (DFDBA) Compared to (DFDBA) in Treatment of Intraosseous Defects in Patients With Stage III Periodontitis: A Randomized Clinical Trial

Cairo University1 site in 1 country20 target enrollmentSeptember 20, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Intrabony Periodontal Defect
Sponsor
Cairo University
Enrollment
20
Locations
1
Primary Endpoint
Clinical attachment level gain (CAL)
Last Updated
5 years ago

Overview

Brief Summary

Clinical and radiographic evaluation of injectable platelet rich fibrin (i-PRF) and demineralized freeze-dried bone allograft (DFDBA) compared to demineralized freeze-dried bone allograft (DFDBA) alone in management of intraosseous defects in stage III periodontitis patients.

Detailed Description

Intraosseous defects are defined by the apical location of the periodontal pocket to the alveolar crest. In a recent radiographic study employing cone-beam computed tomography, a high prevalence of intraosseous defects 83% has been reported. Treatment of intraosseous defects is clinically challenging, as they often require complex regenerative periodontal therapy. Current regenerative techniques often employed in treatment of intraosseous defects demonstrate variation in improvement of clinical outcomes and degree of periodontal regeneration achieved.

Registry
clinicaltrials.gov
Start Date
September 20, 2019
End Date
December 20, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mashaal Mohammed Abdullah Mohammed

Principal Investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Type 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 ≥ 5 mm and pocket depth ≥ 6 mm.
  • Defect not extending to a root furcation area
  • Vital teeth
  • Non-smokers.
  • No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
  • No periodontal therapy carried out in the past 6 months.
  • Able to sign an informed consent form.
  • Patients age between 25 and 50 years old.
  • Patients who are cooperative, motivated, and hygiene conscious.
  • Systemically free according to Cornell Medical Index

Exclusion Criteria

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

Outcomes

Primary Outcomes

Clinical attachment level gain (CAL)

Time Frame: CAL will be measured at base line, 3, 6, and 9 months postoperative

CAL will be measured from the cemento-enamel junction to the bottom of the gingival sulcus/periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth.

Secondary Outcomes

  • Probing Depth (PD)(PD will be measured at base line, 3, 6, and 9 months postoperative)
  • Gingival Recession Depth (RD)(RD will be measured at base line, 3, 6, and 9 months postoperative)
  • Radiographic defect fill (IBD)(Radiographic defect fill will be measured at base line, 6, and 9 months postoperative)
  • Post-surgical patient satisfaction(After 9 months postoperative)

Study Sites (1)

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