Chronic Periodontitis, Concentrated Growth Factors, Intrabony Periodontal Defect
Conditions
Keywords
Beta-Tricalcium Phosphate, regeneration, concentrated growth factors
Brief summary
This clinical study aimed to evaluate the efficacy of biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors in the treatment of periodontal intra-bony defects, as compared with biodegradable gelatin/beta-tricalcium phosphate sponges alone.
Detailed description
40 intra-bony defects in 40 patients will be selected from outpatient clinic of Oral Periodontology Clinic Faculty of Dentistry, Tanta University to participate in this study. Each defect had intra-bony depth \> or = 4 mm and probing pocket depth (PPD) \> or = 6 mm. Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group). Gingival index (GI), bleeding on probing, Probing pocket depth and clinical attachment level (CAL) will assessed at baseline, 3, and 6 months at the site to be treated. Cone beam radiographs evaluation will be taken at baseline, and 6 months after surgery.
Interventions
PROCEDUREopen flap debridement
Open flap for removal of diseased periodontal tissues and necrotic cementum
OTHERuse of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors
use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate incorporating Concentrated Growth Factors in Periodontal Defect
OTHERuse of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone
use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in the Intrabony Periodontal Defect
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
40 Patients will be randomly assigned to either test or control group. 20 patients will be treated by surgery plus biodegradable gelatin/beta-tricalcium phosphate sponges alone. (control group), the other 20 patients will be treated with the same surgical technique plus biodegradable gelatin sponge loaded with Beta-tricalcium phosphate socked in concentrated growth factors (test group).
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* systemically healthy patients were selected * patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing. * Patients should demonstrate their ability to maintain good oral hygiene
Exclusion criteria
* Smokers and pregnant patients. * Medically compromised patients and systemic conditions precluding periodontal surgery. * Subjects who do not comply with oral hygiene measures as evidenced in recall visits. * Sites with tooth mobility * Restoration or caries in the site to be treated or non-vital tooth * Restoration or caries in the site to be treated or non-vital tooth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gingival index | 6months | gingival index will be recorded at baseline, 3, and 6 months at the site to be treated |
| bleeding on probing | 6 months | bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated |
| probing pocket depth | 6 months | probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated |
| clinical attachment level | 6 months | clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated |
| cone beam x ray measuring defect area | 6 months | defect area will be recorded at baseline, and 6 months at the site to be treated |
| cone beam x ray measuring bone density | 6 months | bone density will be recorded at baseline, and 6 months at the site to be treated |
Countries
Egypt
Outcome results
None listed