Clinical trial NCT03924336: The Effect of A-PRF+ Versus Open Flap Debridement in the Treatment of Patients With Stage III Periodontitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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
* 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

Primary outcomes:
measure: Clinical Attachment Level (CAL) gain
timeFrame: Change from Baseline Clinical Attachment Level (CAL) at 9 months
Secondary outcomes:
measure: Probing Depth (PD)
timeFrame: Probing Depth will be measured at base line,3,6, and 9 months postoperative
measure: Radiographic defect fill
timeFrame: Radiographic defect fill will be measured at 6,9,months
measure: Gingival Recession Depth (RD)
timeFrame: Gingival Recession Depth will be measured at base line,3,6, and 9 months postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
Study officials:
affiliation: Cairo University
name: Manal Hosny, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.