Clinical Effect of APRF With DFDBA Compare to Collagen Membrane With DFDBA in Intraosseous Defect

Intrabony Periodontal Defect Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03922503
• Other study ID #: 01091495663
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: December 30, 2021

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrabony Periodontal Defect
• Periodontitis

Intervention

Procedure:
• Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA)
In A-PRF assigned group, one PRF will be cut into small pieces and added to the Demineralized freeze-dried bone allograft (DFDBA) in a ratio of 1:1 and the mixture is applied into the intraosseous defect, and the other will be used to prepare the membrane to cover the defect as a barrier.The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures.
• Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)
After debridement and intraoperative recordings, in the control group, Demineralized freeze-dried bone allograft (DFDBA) will be applied to the bone defect without overfilling and is protected by a collagen membrane, then 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)

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: 10.3109/0 — View Citation

Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical attachment level (CAL)	CAL will be measured from the CEJ to the bottom of the gingival sulcus/periodontal pocket using UNC periodontal probe at six sites per tooth.	CAL will be measured at base line, 3, 6, 9, 12 months postoperative
Secondary	Pobing Depth (PD)	PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using UNC periodontal probe at six sites per tooth.	PD will be measured at base line, 3, 6, 9, 12 months postoperative
Secondary	Gingival Recession Depth (RD)	RD will be measured from the CEJ to the most apical extension of the gingival margin using UNC periodontal probe at six sites per tooth	RD will be measured at base line, 3, 6, 9, 12 months postoperative
Secondary	Radiographic defect fill (IBD)	IBD will be measured from the alveolar bone crest to the base of the defect at baseline and after 6 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 IBD depth was measured by a computer-aided software program	IBD will be measured at base line, 3, 6, 9, 12 months postoperative
Secondary	Post-surgical patient satisfaction	A 3-item questionnaire will be asked to the patients and shall use a 7-point answer scale These items will be: • Would you experience the same surgery another time?; Would you advice others with the surgery?; To what extent are you satisfied with the results?	After 12 months postoperative