Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of A-PRF Versus Open Flap Debridement in the Treatment of Patients With Stage III Periodontitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03924336
Recruitment Status : Completed
First Posted : April 23, 2019
Last Update Posted : December 29, 2021
Sponsor:
Information provided by (Responsible Party):
Yasser Ali Abdu, Cairo University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Intrabony Periodontal Defect Procedure: Advanced- platelets rich fibrin (A-PRF) + Open flap debridement (OFD) Procedure: Open flap debridement (OFD) alone Not Applicable

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Due to the type of intervention only the outcome assessor and the statistician will be blinded.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 30, 2019
Actual Primary Completion Date : September 7, 2021
Actual Study Completion Date : September 7, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Advanced- platelets rich fibrin with open flap debridement
Mucoperiosteal flaps will be elevated using an intrasulcular incision buccally and palatally or lingually. Then the defects will be thoroughly debrided using curettes and ultrasonic scalers. The clinical measurements will be then recorded. After debridement and intraoperative recordings, , one PRF of the required size will be filled into the intraosseous defect, and the other will be used to prepare the membrane that will be used to cover the defect as a barrier. The mucoperiosteal flaps will be repositioned and secured in place using 4-0 silk sutures
 Procedure: Advanced- platelets rich fibrin (A-PRF) + Open flap debridement (OFD)
Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded , one PRF of the required size will be filled into the intraosseous defect, and the other will be used to prepare the membrane that will be used to cover the defect as a barrier. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures
Active Comparator: Open flap debridement (OFD)
Mucoperiosteal flaps will be elevated using an intrasulcular incision buccally and palatally or lingually. Then the defects will be thoroughly debrided using curettes and ultrasonic scalers. The clinical measurements will be then recorded. After debridement and intraoperative recordings, The interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.
 Procedure: Open flap debridement (OFD) alone
Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded. After debridement and intraoperative recordings, interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Probing Depth (PD) [ Time Frame: Probing Depth will be measured at base line,3,6, and 9 months postoperative ]
    Probing Depth (PD) will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth

  2. Radiographic defect fill [ Time Frame: Radiographic defect fill will be measured at 6,9,months ]
    The depth of intrabony defect (IBD) will be measured from the alveolar bone crest to the base of the defect at baseline and after six months to detect the amount of bone fill Individually customized bite blocks and parallel-angle technique will be used to obtain standardized radiographs. Radiographs will be scanned and the radiographic (intrabony defect) IBD depth was measured by a computer-aided software program

  3. Gingival Recession Depth (RD) [ Time Frame: Gingival Recession Depth will be measured at base line,3,6, and 9 months postoperative ]
    Gingival Recession Depth (RD) will be measured from the cemento enamel junction (CEJ) to the most apical extension of the gingival margin using University of North Carolina (UNC) periodontal probe at six sites per tooth


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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 (Broadbent, 1951).

Exclusion Criteria:

  • Pregnancy or breast feeding
  • The presence of an orthodontic appliance
  • Teeth mobility greater than grade I
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924336


Locations
Layout table for location information
Egypt
Faculty of Dentistry Cairo University
Cairo, Egypt, 12613
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Study Director: Manal Hosny, Professor Cairo University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Yasser Ali Abdu, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03924336    
Other Study ID Numbers: 01003884812
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: December 29, 2021
Last Verified: December 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yasser Ali Abdu, Cairo University:
stage 3 periodontitis
A-PRF
Advanced platelet rich fibrin
open flap debridement
 OFD
2-wall intraosseous defect
3-wall intraosseous defect
Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases