Atorvastatin as an Adjunct to DFDBA in Intrabony Defects

Kamineni Institute of Dental Sciences

Status and phase: Completed; Phase 4

Conditions: Chronic Periaortitis; Intrabony Periodontal Defect

Treatments: Drug: DFDBA with atorvastatin; Biological: DFDBA

Study type: Interventional

Funder types: Other

Identifiers

NCT03009097

kamineni perio

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

DFDBA

Active Comparator group

Description:

13 intrabony defects in chronic periodontitis patients were treated with DFDBA

Treatment:

Biological: DFDBA

DFDBA with Atorvastatin

Active Comparator group

Description:

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

Treatment:

Drug: DFDBA with atorvastatin