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

Not Applicable

Completed

• Conditions: Intrabony Periodontal Defect
• Interventions: Procedure: Advanced- platelets rich fibrin (A-PRF+) + Open flap debridement (OFD); Procedure: Open flap debridement (OFD) alone

• Registration Number: NCT03924336
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-04-19
• Study First Posted: 2019-04-23
• Study Start: 2019-09-30
• Primary Completion: 2021-09-07
• Study Completion: 2021-09-07
• Status Verified: 2021-12
• Last Update Submitted: 2022-04-17
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advanced- platelets rich fibrin plus with open flap debridement	Advanced- platelets rich fibrin (A-PRF+) + 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, A-PRF+ of the required size will be filled into the intraosseous defect, the mucoperiosteal flaps will be repositioned and secured in place using 4-0 silk sutures
Open flap debridement (OFD)	Open flap debridement (OFD) alone	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.

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level (CAL) gain	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

Name	Time	Method
Probing Depth (PD)	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
Radiographic defect fill	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
Gingival Recession Depth (RD)	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

Trial Locations

Locations (1)

Faculty of Dentistry Cairo University; 🇪🇬 Cairo, Egypt