Atorvastatin as an Adjunct to DFDBA in Intrabony Defects

Intrabony Periodontal Defect Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009097
• Other study ID #: kamineni perio
• Status: Completed
• Phase: Phase 4
• First received: December 28, 2016
• Last updated: January 3, 2017
• Start date: April 2013
• Est. completion date: August 2014

Study information

• Verified date: December 2016
• Source: Kamineni Institute of Dental Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periaortitis
• Intrabony Periodontal Defect
• Retroperitoneal Fibrosis

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kamineni Institute of Dental Sciences

References & Publications (1)

Pradeep AR, Kumari M, Rao NS, Martande SS, Naik SB. Clinical efficacy of subgingivally delivered 1.2% atorvastatin in chronic periodontitis: a randomized controlled clinical trial. J Periodontol. 2013 Jul;84(7):871-9. doi: 10.1902/jop.2012.120393. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone fill in mm was measured by taking radiographs		6 months	Yes