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Atorvastatin as an Adjunct to DFDBA in Intrabony Defects

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ClinicalTrials.gov Identifier: NCT03009097
Recruitment Status : Completed
First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
ETIKA RATHI, Kamineni Institute of Dental Sciences

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Periaortitis Intrabony Periodontal Defect Biological: DFDBA Drug: DFDBA with atorvastatin Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: "Comparative Evaluation Of The Efficacy Of Atorvastatin Gel As An Adjunct To Allografts In The Treatment Of Intrabony Defects" - A Clinico Radiological Study
Study Start Date : April 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014


Arm Intervention/treatment
Active Comparator: DFDBA
13 intrabony defects in chronic periodontitis patients were treated with DFDBA
Biological: DFDBA
13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA)
Other Name: Allograft

Active Comparator: DFDBA with Atorvastatin
13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel.
Drug: DFDBA with atorvastatin
13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel
Other Name: atorvastatin gel




Primary Outcome Measures :
  1. bone fill in mm was measured by taking radiographs [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Systemically healthy individual based on personal and medical history.
  2. 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:

  1. Patients diagnosed and treated for systemic disease
  2. Pregnant and Lactating women
  3. Smokers
  4. History of allergy to statin group or patients on systemic statin therapy.
  5. History of antibiotic or periodontal therapy for the past 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009097


Sponsors and Collaborators
Kamineni Institute of Dental Sciences
Investigators
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Principal Investigator: Etika Rathi, MDS Kamineni Institute of Dental Sciences
Publications:
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Responsible Party: ETIKA RATHI, Principal investigator, Kamineni Institute of Dental Sciences
ClinicalTrials.gov Identifier: NCT03009097    
Other Study ID Numbers: kamineni perio
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: December 2016
Keywords provided by ETIKA RATHI, Kamineni Institute of Dental Sciences:
Chronic periodontitis
atorvastatin
intrabony defect
Additional relevant MeSH terms:
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Retroperitoneal Fibrosis
Fibrosis
Pathologic Processes
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors