Curcumin-Simvastatin-EDTA in the Treatment of Periodontitis

Study Overview
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Brief Summary
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Among the root conditioning materials is the Ethylenediaminetetraacetic acid (EDTA). EDTA exposes the collagen fibers on dentin surfaces and also enhances early cell colonization. Statins have an anti-inflammatory effect, inhibit the bone resorption and stimulate the bone formation. Curcumin is effective in preventing periodontal disease destruction by targeting both bacteria and host inflammatory cells. Curcumin has anti- inflammatory, antioxidant, anticarcinogenic, antiviral, and antimicrobial functions. This study will be carried out to examine the effect of simvastatin-curcumin paste following EDTA root surface etching when used in conjunction with open flap debridement treating deep periodontal pockets (suggesting that it may have positive effect)

Detailed Description
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The present study entailed thirty patients having stage II or stage III, Grade A periodontitis with 30 intrabony defects. Patients were divided into three groups; group I was subjected to open flap debridement only. Group II was subjected to open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin). Group III was subjected to open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).Clinical parameters including plaque index, sulcus bleeding index, probing depth and clinical attachment level were recorded pre-surgical. Moreover, radiographic examination was performed by cone beam computed tomography (CBCT) just before the surgery . Vertical bone defects were exposed by full thickness mucoperiosteal flap following intrasulcular incision and thorough debridement was performed. Group II received local application of curcumin-simvastatin paste .Group III received curcumin-simvastatin paste after debridement and 24 % EDTA. The same initial clinical parameters were recorded three and six months postoperatively. Radiographic measurements were recorded six months post surgically.

Official Title
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Curcumin-Simvastatin Release Profile in the Gingival Crevicular Fluid Following EDTA Root Surface Etching in the Surgical Treatment of Intrabony Periodontal Defects - A Biochemical and Clinical Study

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: currettage
* Drug: curcumin simvastatin paste
* Drug: EDTA root conditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient suffering at least a single posterior 2-3 wall periodontal Pocket of depth ≥ 5 mm, attachment loss ≥3 mm, intrabony component ≥3 mm, plaque index ≤1 (Sillness and Loe, 1964) and sulcus bleeding index ≤1 (Mühlemann & Son, 1971). All these criteria were determined after phase I conventional periodontal therapy. Systemically healthy as evidenced by burket's oral medicine health history question questionnaire (Glick et al., 2008). Patients available during follow-up periods Exclusion Criteria: Smoking Patient unwilling to comply with periodontal hygienic instructions Patients under any long-term chronic medication Vulnerable individuals

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: open flap debridement only<br>surgical treatment of periodontal defects | Procedure: currettage<br>* open flap debridement<br>* Other names: surgical treatment of periodontal defects;|
| Active Comparator: curcumin and simvastatin<br>open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin). | Procedure: currettage<br>* open flap debridement<br>* Other names: surgical treatment of periodontal defects;Drug: curcumin simvastatin paste<br>* Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.<br>* Other names: open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).;|
| Active Comparator: EDTA, curcumin and simvastatin<br>open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin). | Procedure: currettage<br>* open flap debridement<br>* Other names: surgical treatment of periodontal defects;Drug: curcumin simvastatin paste<br>* Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.<br>* Other names: open flap debridement followed by application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).;Drug: EDTA root conditioning<br>* EDTA is an aminopolycarboxylic acid and a colourless, water-soluble solid<br>* Other names: open flap debridement followed by 24% EDTA root surface etching and application of curcumin-simvastatin paste (2% curcumin and 1.2% simvastatin).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical score | Probing depth (PD): evaluate the average reduction in probing depth measured in millimeters. Reduction in probing depth indicates that EDTA, simvastatin, and curcumin have positive effects in treatment. | change from base line to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontitis, curcumin, simvastatin, EDTA