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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

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

Clinicaltrials.gov identifier NCT03924336

Recruitment Status Not yet recruiting

First Posted April 23, 2019

Last update posted April 23, 2019

Study Description

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:Intrabony Periodontal Defect
  • Intervention/Treatment: Procedure: Advanced- platelets rich fibrin (A-PRF) + open flap debridement
    Procedure: Open flap debridement alone
  • Phase: N/A
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
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • 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
  • Estimated Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: April 2021
Arms and interventions
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
Elevation of flap.Thorough debridedment 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 abarrier. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures
Active Comparator: 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 dclinical measurements will be then recorde.After debridement and intraoperative recordings, The interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.
Procedure: Open flap debridement alone
Elevation of flap.Thorough debridedment 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
  • Primary Outcome Measures: 1. Clinical Attachment Level (CAL) gain [ Time Frame: Change from Baseline CAL at 9 months ]
    CAL will be measured from the CEJ to the bottom of the gingival sulcus/periodontal pocket using 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 ]
    PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using UNC periodontal probe at six sites per tooth
  • 2. Radiographic defect fill (IBD) [ Time Frame: Radiographic defect fill (IBD) 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 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 ]
    RD will be measured from the CEJ to the most apical extension of the gingival margin using UNC periodontal probe at six sites per tooth
Eligibility Criteria
  • Ages Eligible for Study: 25 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
Contacts

Contact: Yasser Abdu 00201003884812 yasser.abdu@dentistry.cu.edu.eg

Contact: Manal Hosny manhosny@gmail.com

Locations
Sponsors and Collaborators

Cairo University

Investigators

Study Director: Manal Hosny, Professor faculty of dentistry Cairo university

More Information