Atorvastatin as an Adjunct to DFDBA in Intrabony Defects

Study Overview
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Brief Summary
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Periodontitis is a major oral health problem which leads to the progressive destruction of periodontal ligament and alveolar bone with pocket formation, recession or both. The ultimate goal of periodontal therapy is to regenerate the lost periodontal tissue. The most common form of regenerative periodontal therapy is the use of bone grafts which stimulate bone formation by the processes of osteoinduction and osteoconduction. Statins are a group of lipid lowering drugs which inhibit bone resorption by inhibition of the enzyme HMG-CoA reductase. They also stimulate new bone formation by local stimulation of BMP-2, a major bone growth regulatory factor. They also have anti-inflammatory and anti oxidant properties. Very few studies exist evaluating the beneficiary effects of grafts if combined with the statins which might enhance the regeneration by bone grafts. Hence, the present study was carried out in an attempt to comparatively evaluate clinically and radiologically, the efficacy of atorvastatin gel as an adjunct to allograft in the treatment of intrabony defects.

Detailed Description
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A total of 26 intrabony defects in patients with chronic periodontitis as diagnosed by radiographs, were selected for the study after taking an informed consent. The selected sites were randomized in 2 treatment groups. Group I - sites were treated with allograft (DFDBA) Group II - sites were treated with allograft (DFDBA) in combination with Atorvastatin gel. Clinical parameters like probing depth and clinical attachment level and radiological assessment of intrabony defect fill were done at baseline and 3 and 6 months postoperatively.

Official Title
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Comparative Evaluation Of The Efficacy Of Atorvastatin Gel As An Adjunct To Allografts In The Treatment Of Intrabony Defects - A Clinico Radiological Study

Conditions
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Chronic Periaortitis, Intrabony Periodontal Defect

Intervention / Treatment
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* Biological: DFDBA
* Drug: DFDBA with atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy individual based on personal and medical history. Presentation of untreated Chronic Periodontitis with intrabony defect having probing pocket depth (PPD) ≥5mm or clinical attachment loss of ≥ 3mm and radiographic signs of angular bone loss. Exclusion Criteria: Patients diagnosed and treated for systemic disease Pregnant and Lactating women Smokers History of allergy to statin group or patients on systemic statin therapy. History of antibiotic or periodontal therapy for the past 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DFDBA<br>13 intrabony defects in chronic periodontitis patients were treated with DFDBA | Biological: DFDBA<br>* 13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA)<br>* Other names: Allograft;|
| Active Comparator: DFDBA with Atorvastatin<br>13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel. | Drug: DFDBA with atorvastatin<br>* 13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel<br>* Other names: atorvastatin gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone fill in mm was measured by taking radiographs |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic periodontitis, atorvastatin, intrabony defect