The Use of Injectable Plasma Versus the Use of Simvastatin Gel in Surgical Management of Bony Defect in Dentistry

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Use of Injectable Plasma Rich Fibrin (I-PRF) Versus Simvastatin Gel in Surgical Management of Infra-bony Defects (A Randomized Controlled Clinical Trial)

Conditions
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Intra-bony Pockets

Intervention / Treatment
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* Drug: Simvastatin
* Other: injectable plasma rich fibrin


Participation Criteria
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Eligibility Criteria
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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 )

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simvastatin 1.2%gel<br>simvastatin 1.2%gel applied after open flap debridment in group I | Drug: Simvastatin<br>* 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<br>|
| Experimental: I-prf<br>Injectable plasma rich fibrin will be collected from each patient in group II and the applied after open flap debridment | Other: injectable plasma rich fibrin<br>* 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<br>* Other names: i-prf;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index (PI) | clinical score | change from basline at 6 months | 
| Gingival index (GI) | clinical score | change from basline at 6 months | 
| Probing depth (PD) | clinical score | change from basline at 6 months | 
| Clinical attachment level (CAL) | clinical score | change from basline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiographIc | assess the alveolar bone level radiographically | from baseline at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vertical bone loss treatment, intra-bony pocket, I-prf, infra-bony pocket defect, simvastation in pockets