Atorvastatin as an Adjunct to DFDBA in Intrabony Defects

Phase 4

Completed

• Conditions: Chronic Periaortitis; Intrabony Periodontal Defect
• Interventions: Biological: DFDBA; Drug: DFDBA with atorvastatin

• Registration Number: NCT03009097
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-12
• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2017-01-03
• Last Update Submitted: 2017-01-03
• Study First Posted: 2017-01-04
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DFDBA	DFDBA	13 intrabony defects in chronic periodontitis patients were treated with DFDBA
DFDBA with Atorvastatin	DFDBA with atorvastatin	13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel.

Primary Outcome Measures

Name	Time	Method
bone fill in mm was measured by taking radiographs	6 months