Atorvastatin as an Adjunct to DFDBA in Intrabony Defects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-08-31

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.

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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.

Conditions

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Chronic Periaortitis Intrabony Periodontal Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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DFDBA

13 intrabony defects in chronic periodontitis patients were treated with DFDBA

Group Type ACTIVE_COMPARATOR

DFDBA

Intervention Type BIOLOGICAL

13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA)

DFDBA with Atorvastatin

13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel.

Group Type ACTIVE_COMPARATOR

DFDBA with atorvastatin

Intervention Type DRUG

13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel

Interventions

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DFDBA

13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA)

Intervention Type BIOLOGICAL

DFDBA with atorvastatin

13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel

Intervention Type DRUG

Other Intervention Names

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Allograft atorvastatin gel

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No