Intra-bony Pockets
Conditions
Keywords
intra-bony pocket, I-prf, infra-bony pocket defect, vertical bone loss treatment, simvastation in pockets
Brief summary
Simvastatin (SMV) is one of the family members of statins, it has been showed in many previous studies that the simvastatin when dissolved with methylcellulose in situ gel with a concentration of 1.2% (SMV) approximately, can have a significant decrease in the pocket depth, regain the clinical attachment loss (CAL), and improve the bone level. and the platelets concentrate has been introduced which is the injectable plasma rich fibrin (I-PRF), as it contains platelets and leukocytes, stem cells and endothelial cells that why it is called blood concentrate . So, it is proposed as treatment option in different periodontal procedures such as treatment of intra-bony defects,
Detailed description
Group I ( Experimental group): will include 12 patients undergoing open flap debridement (OFD) followed by single application of I-PRF. Oral Hygiene measure will be instructed following treatment and maintenance visits will be given to them. Group II (Control group): will include 12 patients undergoing open flap debridement (OFD) followed by application of 1.2% simvastatin gel. Oral Hygiene measure will be instructed following treatment and maintenance visits will be given to them. * Oral hygiene instructions will be given to all patients. * Full mouth Scaling and root planing (SRP) will be performed under local anesthesia. * 4 to 8 weeks after the non-surgical periodontal therapy patients will be reassessed clinically and radiographically For all patients who are suitable for the study the following clinical and radiographic evaluation parameters will be measured: (All parameters will be recorded Pre-operatively (base line) and 6 months Post operatively by an examiner who will be masked to the type of treatment received by the individuals).
Interventions
DRUGSimvastatin
Statins are first known as drugs that decrease the cholesterol level by inhibiting hydroxy-methyl-glutaryl co-enzyme-A reductase as they improve the lipid profile and help in the treatment of many cardiac diseases and has a role in osteoblasts diffrentiation
OTHERinjectable plasma rich fibrin
I- PRF is obtained by taking a blood sample from patients and then is centrifuged for three minutes at 3300 rpm, the I-PRF first will be in the form of liquid and then coagulate after few minutes from the injection
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* • Age range between 25 and 40 years * Patients with severe chronic periodontitis having probing depth (PD) ≥6 mm and clinical attachment loss (CAL) ≥5 mm , or Stage III periodontitis * Patient having vertical bone loss ≥3 mm (distance between alveolar crest and base of the defect as confirmed by preoperative intraoral periapical radiographs using standardized parallel technique.) * Good compliance with the plaque control instructions following initial therapy * Availability for follow up and maintenance program.
Exclusion criteria
* • Patient with any systemic disease or conditions * Patient using antibiotic, anti-inflammatory, and immunosuppressive therapy during the preceding 3 months before the start of trial and during the study. * Patients who have undergone any periodontal treatment in the last 6 months * Pregnant and Lactating. * Reported allergy to any type of statins * Subjects who were tobacco or alcohol users * Vulnerable group of patients (e.g.: prisoners , handicapped , or decisionally impaired individuals )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque index (PI) | change from basline at 6 months | clinical score |
| Gingival index (GI) | change from basline at 6 months | clinical score |
| Probing depth (PD) | change from basline at 6 months | clinical score |
| Clinical attachment level (CAL) | change from basline at 6 months | clinical score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| radiographIc | from baseline at 6 months | assess the alveolar bone level radiographically |
Countries
Egypt
Outcome results
None listed