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

Not Applicable
Conditions
Intrabony Periodontal Defect
Registration Number
NCT03922503
Lead Sponsor
Cairo University
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
22
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in clinical attachment level (CAL)CAL will be measured at base line, 3, 6, 9, 12 months postoperative

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.

Secondary Outcome Measures
NameTimeMethod
Gingival Recession Depth (RD)RD will be measured at base line, 3, 6, 9, 12 months postoperative

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

Radiographic defect fill (IBD)IBD will be measured at base line, 3, 6, 9, 12 months postoperative

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

Post-surgical patient satisfactionAfter 12 months postoperative

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?

Pobing Depth (PD)PD will be measured at base line, 3, 6, 9, 12 months postoperative

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.

Trial Locations

Locations (1)

Faculty of dentistry cairo university

🇪🇬

Cairo, Egypt

Faculty of dentistry cairo university
🇪🇬Cairo, Egypt

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