Intrabony Periodontal Defect
Conditions
Keywords
Albumin Platelet Rich Fibrin (Alb-PRF), Minimally Invasive Surgical Technique (MIST), Stage 3 periodontitis, Intrabony defect
Brief summary
Clinical Evaluation of Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The goal of this clinical trial is to compare Injectable Albumin Platelet Rich Fibrin Versus Platelet Rich Fibrin in the Management of Intra-bony Defect in Stage-III Periodontitis Patients. The main question aims to answer are: will Albumin Platelet Rich Fibrin (Alb-PRF) as adjunct to minimally invasive surgical technique (MIST) be superior in terms of improvement in clinical parameters compared to the use of PRF with MIST.
Interventions
PROCEDUREAlbumin Platelet Rich Fibrin (Alb-PRF) combined with minimally invasive surgical technique (MIST)
Albumin-PRF will be placed into intrabony defect
MIST will be the surgical access for treatment of Intrabony defect
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
1. Stage III periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intrabony defect ≥3 mm in depth (assessed by bone sounding, radiographic examination) with clinical attachment level (CAL) ≥5mm and probing pocket depth (PPD) ≥6 mm with no defect extending to a root furcation area. 2. Vital teeth. 3. No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months. 4. No periodontal therapy carried out in the past 6 months. 5. Ability to sign an informed consent form. 6. Patients age ≥18 years old. 7. Patients who are cooperative, motivated, and hygiene conscious. 8. Systemically free according to Cornell Medical Index.
Exclusion criteria
1. Patient undergoing orthodontic treatment. 2. Pregnant females or breast feeding. 3. Smokers. 4. Teeth mobility greater than grade I.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level (CAL) | CAL will be measured at base line, 6, and 9 months postoperative | CAL will be measured from the cemento-enamel junction to the bottom of the gingival sulcus/periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing Depth (PD) | CAL will be measured at base line, 6, and 9 months postoperative | PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using the University of North Carolina periodontal probe at six sites per tooth. |
| Radiographic Linear Defect Depth (RLDD) | Radiographic defect fill will be measured at base line, 6, and 9 months postoperative | Individually customized bite blocks will be fabricated for each patient and parallel-angle technique will be employed using X-ray film holding system. Periapical radiograph PSP sensor size two and standardized exposure setting of 60 kVp, 8 mA, 0.7 mm, and 0.10 s will be used. RLDD will be measured as the depth of the intrabony defect from the alveolar crest (AC) to the defect base (DB) |
| Recession Depth (RD) | RD will be measured at base line, 6, and 9 months postoperative | RD will be measured from the cemento-enamel junction to the most apical extension of the gingival margin using the University of North Carolina periodontal probe at six sites per tooth. |
| Post-operative Pain | During first week postoperative | The visual analogue scale (VAS) score (0-10) |
| Radiographic defect fill (RDF) | Radiographic defect fill will be measured at base line, 6, and 9 months postoperative | Calculation of bone fill in mm will be done by a subtraction of follow-up from baseline RLDD values |
Contacts
Primary ContactMashaal Mohammed, Master
Backup ContactManal Hosny, Professor
Outcome results
None listed