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

Cairo University22 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intrabony Periodontal Defect

Interventions

Advanced- platelets rich fibrin (A-PRF+) + Open flap debridement (OFD)PROCEDURE

Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded , A-PRF+ of the required size will be filled into the intraosseous defect. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures

Open flap debridement (OFD) alonePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Dentistry Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

Clinical Attachment Level (CAL) gain

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

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

Secondary Outcomes

Probing Depth (PD)

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

Time frame: Probing Depth will be measured at base line,3,6, and 9 months postoperative

Radiographic defect fill

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

Time frame: Radiographic defect fill will be measured at 6,9,months

Gingival Recession Depth (RD)

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

Time frame: Gingival Recession Depth will be measured at base line,3,6, and 9 months postoperative

Data from ClinicalTrials.gov

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