Atorvastatin as an Adjunct to DFDBA in Intrabony Defects

NCT03009097 | Completed Phase 4

• 1 other identifier: kamineni perio
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periaortitis; Intrabony Periodontal Defect

Keywords

Chronic periodontitis; atorvastatin; intrabony defect

Outcome Measures

Primary Outcomes (1)

• bone fill in mm was measured by taking radiographs

  6 months

Study Arms (2)

DFDBA

ACTIVE COMPARATOR

13 intrabony defects in chronic periodontitis patients were treated with DFDBA

Biological: DFDBA

DFDBA with Atorvastatin

ACTIVE COMPARATOR

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

Drug: DFDBA with atorvastatin

Interventions

DFDBA BIOLOGICAL

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

Also known as: Allograft

DFDBA

DFDBA with atorvastatin DRUG

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

Also known as: atorvastatin gel

DFDBA with Atorvastatin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy individual based on personal and medical history.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kamineni Institute of Dental Sciences: lead

Related 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. Epub 2012 Oct 2.

  PMID: 23030241 BACKGROUND

MeSH Terms

Conditions

Retroperitoneal Fibrosis; Chronic Periodontitis

Interventions

Transplantation, Homologous; Atorvastatin

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Etika Rathi, MDS

  Kamineni Institute of Dental Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 4, 2017
• Study Start: April 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 4, 2017

Record last verified: 2016-12