Clinical trial NCT03433066: Advanced Platelet Rich Fibrin in Periodontal Angular Defects
Official title: Evaluation of Advanced Platelet-rich Fibrin in Management of Periodontal Intrabony Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrabony Periodontal Defect
Keywords: advanced platelet-rich fibrin
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical study will be conducted on twenty-two (22) interproximal intrabony defects in patients with moderate to severe chronic periodontitis.These patients will be divided randomly into two groups:

* Group I: (test) will include eleven interproximal intrabony defects that will be treated with (Advanced platelet rich fibrin \& biphasic alloplast)
* Group II: (control) will include eleven interproximal intrabony defects that will be treated with (biphasic alloplast mixed with saline.)
Primary purpose: TREATMENT

Brief summary: The aim of this study is to clinically and radiographically evaluate the efficacy of advanced platelet-rich fibrin (A-PRF) when used with biphasic alloplast in the management of intrabony defects in patients with moderate to severe chronic periodontitis.

Detailed description: Biphasic alloplasts have been successfully used in management of intrabony defects. Advanced platelet-rich fibrin is believed to contain higher amount of growth factors and white blood cells than the well known PRF. Although there are some studies on the use of PRF in the treatment of intrabony defects, to date none of them evaluate the effect of the A-PRF. Therefore, a randomized controlled clinical trial was conducted to compare the healing of intrabony defects treated with A-PRF/biphasic alloplast combination and to those obtained with biphasic alloplast mixed with saline. Using a parallel arm design, 22 intrabony defects were randomly treated with either biphasic alloplast mixed with saline (control group) or with A-PRF/ biphasic alloplast combination (test group). The following clinical parameters were recorded at baseline, three and six months postoperatively : plaque index (PI), modified gingival index (MGI), probing depth (PD), clinical attachment level (CAL), while these radiographic measurements were recorded at baseline and six months postoperatively: bone fill and bone density.

Eligibility criteria: Inclusion Criteria:

* They should be diagnosed as having moderate -severe chronic periodontitis according to the American Academy of Periodontology classification on gingival and periodontal diseases (1999)
* Clinical attachment loss (CAL) ,radiographic evidence of the presence of at least one intrabony defect.
* Patient's age between 25 to 55 years.
* Both sexes.
* No periodontal surgeries in the area of interest during the previous 6 months.
* The presence of intrabony defects (IBD) ≥3 mm deep (distance between alveolar crest and deepest point in the defect estimated from radiographs and confirmed upon surgical exposure).
* An interproximal probing depth (PD) ≥5 mm and clinical attachment loss (CAL) ≥3mm after phase I therapy in maxillary/ mandibular teeth.
* The presence of an adequate zone of keratinized gingiva at the facial aspect of the selected tooth.

Exclusion Criteria:

* Patients who could not maintain O'leary plaque index (54) ≤10% after phase I therapy.
* Aggressive periodontitis patients.
* Patients with systemic conditions known to affect the periodontal status, or, under medications known to affect the outcomes of periodontal therapy.
* Pregnancy/lactation.
* Smoking and tobacco use in any form.
* Non vital teeth and teeth with grade III mobility.

Primary outcomes:
measure: Clinical attachment level change
timeFrame: Baseline , 3 and 6 months posoperatively
Secondary outcomes:
measure: Probing depth change:
timeFrame: Baseline , 3 and 6 months postoperatively
measure: Radiographic bone density
timeFrame: Baseline and 6 months postoperatively
measure: Radiographic bone fill
timeFrame: Baseline and 6 months postoperatively
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Periodontology department, Faculty of Dentistry, Alexandria University
Study officials:
name: Mohy Eldin A. ElRashidy, Professor
role: STUDY_CHAIR
References:
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citation: Perut F, Filardo G, Mariani E, Cenacchi A, Pratelli L, Devescovi V, Kon E, Marcacci M, Facchini A, Baldini N, Granchi D. Preparation method and growth factor content of platelet concentrate influence the osteogenic differentiation of bone marrow stromal cells. Cytotherapy. 2013 Jul;15(7):830-9. doi: 10.1016/j.jcyt.2013.01.220.
citation: Dohan Ehrenfest DM, Del Corso M, Diss A, Mouhyi J, Charrier JB. Three-dimensional architecture and cell composition of a Choukroun's platelet-rich fibrin clot and membrane. J Periodontol. 2010 Apr;81(4):546-55. doi: 10.1902/jop.2009.090531.
citation: Ajwani H, Shetty S, Gopalakrishnan D, Kathariya R, Kulloli A, Dolas RS, Pradeep AR. Comparative evaluation of platelet-rich fibrin biomaterial and open flap debridement in the treatment of two and three wall intrabony defects. J Int Oral Health. 2015 Apr;7(4):32-7.
citation: Agarwal A, Gupta ND, Jain A. Platelet rich fibrin combined with decalcified freeze-dried bone allograft for the treatment of human intrabony periodontal defects: a randomized split mouth clinical trail. Acta Odontol Scand. 2016;74(1):36-43. doi: 10.3109/00016357.2015.1035672. Epub 2015 May 14.