Intrabony Periodontal Defect
Conditions
Keywords
stage 3 periodontitis, A-PRF, Advanced platelet rich fibrin, open flap debridement, OFD, 2-wall intraosseous defect, 3-wall intraosseous defect
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
Interventions
PROCEDUREAdvanced- platelets rich fibrin (A-PRF+) + Open flap debridement (OFD)
Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded , A-PRF+ of the required size will be filled into the intraosseous defect. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures
PROCEDUREOpen flap debridement (OFD) alone
Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded. After debridement and intraoperative recordings, interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to the type of intervention only the outcome assessor and the statistician will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Attachment Level (CAL) gain | Change from Baseline Clinical Attachment Level (CAL) at 9 months | Clinical Attachment Level (CAL) will be measured from the cemento enamel junction (CEJ) to the bottom of the gingival sulcus/periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing Depth (PD) | Probing Depth will be measured at base line,3,6, and 9 months postoperative | Probing Depth (PD) will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using University of North Carolina (UNC) periodontal probe at six sites per tooth |
| Radiographic defect fill | Radiographic defect fill will be measured at 6,9,months | The depth of intrabony defect (IBD) will be measured from the alveolar bone crest to the base of the defect at baseline and after six 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 (intrabony defect) IBD depth was measured by a computer-aided software program |
| Gingival Recession Depth (RD) | Gingival Recession Depth will be measured at base line,3,6, and 9 months postoperative | Gingival Recession Depth (RD) will be measured from the cemento enamel junction (CEJ) to the most apical extension of the gingival margin using University of North Carolina (UNC) periodontal probe at six sites per tooth |
Countries
Egypt
Outcome results
None listed