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

NCT03924336 | Completed

• 1 other identifier: 01003884812
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrabony Periodontal Defect

Keywords

stage 3 periodontitis; A-PRF; Advanced platelet rich fibrin; open flap debridement; OFD; 2-wall intraosseous defect; 3-wall intraosseous defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Probing Depth (PD)

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

• Radiographic defect fill

  Radiographic defect fill will be measured at 6,9,months

• Gingival Recession Depth (RD)

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

Study Arms (2)

Advanced- platelets rich fibrin plus with open flap debridement

EXPERIMENTAL

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

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

Open flap debridement (OFD)

ACTIVE COMPARATOR

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

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

Advanced- platelets rich fibrin plus with open flap debridement

Open flap debridement (OFD) alone PROCEDURE

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.

Open flap debridement (OFD)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Pregnancy or breast feeding
• The presence of an orthodontic appliance
• Teeth mobility greater than grade I

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, 12613, Egypt

Location

Related 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.

  PMID: 25867990 RESULT

• Kobayashi E, Fluckiger 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.

  PMID: 26809431 RESULT

MeSH Terms

Conditions

Periodontitis

Interventions

Single Person

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Manal Hosny, Professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the type of intervention only the outcome assessor and the statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 23, 2019
• Study Start: September 30, 2019
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: April 22, 2022

Record last verified: 2021-12

Locations

EG (1)