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

Intrabony Periodontal Defect Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924336
• Other study ID #: 01003884812
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: September 7, 2021

Study information

• Verified date: December 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 7, 2021
• Est. primary completion date: September 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrabony Periodontal Defect
• Periodontitis

Intervention

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 , 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) 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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Cortellini P, Tonetti MS. Clinical concepts for regenerative therapy in intrabony defects. Periodontol 2000. 2015 Jun;68(1):282-307. doi: 10.1111/prd.12048. Review. — View Citation

Kobayashi E, Flückiger L, Fujioka-Kobayashi M, Sawada K, Sculean A, Schaller B, Miron RJ. Comparative release of growth factors from PRP, PRF, and advanced-PRF. Clin Oral Investig. 2016 Dec;20(9):2353-2360. doi: 10.1007/s00784-016-1719-1. Epub 2016 Jan 25 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline Clinical Attachment Level (CAL) at 9 months
Secondary	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	Probing Depth will be measured at base line,3,6, and 9 months postoperative
Secondary	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	Radiographic defect fill will be measured at 6,9,months
Secondary	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	Gingival Recession Depth will be measured at base line,3,6, and 9 months postoperative