Clinical trial NCT03922503: Clinical Effect of APRF With DFDBA Compare to Collagen Membrane With DFDBA in Intraosseous Defect
Official title: Clinical Evaluation of Advanced Platelet Rich Fibrin With (DFDBA) Compared to Collagen Membrane With (DFDBA) in Treatment of Non-contained Intraosseous Defects in Stage III Periodontitis Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrabony Periodontal Defect
Keywords: Stage III periodontitis
APRF
Advanced Platelet Rich Fibrin
Demineralized freeze-dried bone allograft
DFDBA
Collagen Membrane
non-contained intraosseous defects
one wall intraosseous defects
combined 1- to 2-wall intraosseous defect
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to assess the effectiveness of advanced PRF in combination of Demineralized freeze-dried bone allograft (DFDBA) as compared to collagen membrane in combination with Demineralized freeze-dried bone allograft (DFDBA) treatment of non-contained periodontal intraosseous defects in stage III periodontitis patients.

Detailed description: Treatment of intraosseous periodontal defects represents a clinical challenge; these defects have been detected through clinical and radiographic examination in 18- 51 % of patients with periodontitis. They are often associated with persistent deep pockets and bleeding following conventional periodontal treatment. Complex regenerative periodontal therapy is advocated for management of these defects. The outcomes of regenerative periodontal therapy are positively correlated with the morphology of osseous defects. Non-contained defects are prevalent clinically and have been reported to have a low regenerative potential.

Eligibility criteria: Inclusion Criteria:

* Stage III periodontitis patient having at least one tooth with one wall or combined1- to 2-wall intraosseous defect ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
* Defect not extending to a root furcation area
* Vital teeth
* Non-smokers.
* No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
* No periodontal therapy carried out in the past 6 months.
* Able to sign an informed consent form.
* Patients age between 25 and 50 years old.
* Patients who are cooperative, motivated, and hygiene conscious.
* Systemically free according to Cornell Medical Index

Exclusion Criteria:

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

Primary outcomes:
measure: Change in clinical attachment level (CAL)
timeFrame: CAL will be measured at base line, 3, 6, 9, 12 months postoperative
Secondary outcomes:
measure: Pobing Depth (PD)
timeFrame: PD will be measured at base line, 3, 6, 9, 12 months postoperative
measure: Gingival Recession Depth (RD)
timeFrame: RD will be measured at base line, 3, 6, 9, 12 months postoperative
measure: Radiographic defect fill (IBD)
timeFrame: IBD will be measured at base line, 3, 6, 9, 12 months postoperative
measure: Post-surgical patient satisfaction
timeFrame: After 12 months postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry cairo university
Study officials:
affiliation: Cairo University
name: Manal Hosny
role: STUDY_DIRECTOR
References:
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.
citation: Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.