Atorvastatin as an Adjunct to DFDBA in Intrabony Defects
Primary Purpose
Chronic Periaortitis, Intrabony Periodontal Defect
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
DFDBA
DFDBA with atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periaortitis focused on measuring Chronic periodontitis, atorvastatin, intrabony defect
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
DFDBA
DFDBA with Atorvastatin
Arm Description
13 intrabony defects in chronic periodontitis patients were treated with DFDBA
13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel.
Outcomes
Primary Outcome Measures
bone fill in mm was measured by taking radiographs
Secondary Outcome Measures
Full Information
NCT ID
NCT03009097
First Posted
December 28, 2016
Last Updated
January 3, 2017
Sponsor
Kamineni Institute of Dental Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03009097
Brief Title
Atorvastatin as an Adjunct to DFDBA in Intrabony Defects
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kamineni Institute of Dental Sciences
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periaortitis, Intrabony Periodontal Defect
Keywords
Chronic periodontitis, atorvastatin, intrabony defect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DFDBA
Arm Type
Active Comparator
Arm Description
13 intrabony defects in chronic periodontitis patients were treated with DFDBA
Arm Title
DFDBA with Atorvastatin
Arm Type
Active Comparator
Arm Description
13 intrabony defects in chronic periodontitis patients were treated with DFDBA in combination with Atorvastatin gel.
Intervention Type
Biological
Intervention Name(s)
DFDBA
Other Intervention Name(s)
Allograft
Intervention Description
13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA)
Intervention Type
Drug
Intervention Name(s)
DFDBA with atorvastatin
Other Intervention Name(s)
atorvastatin gel
Intervention Description
13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel
Primary Outcome Measure Information:
Title
bone fill in mm was measured by taking radiographs
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etika Rathi, MDS
Organizational Affiliation
Kamineni Institute of Dental Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23030241
Citation
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.
Results Reference
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Atorvastatin as an Adjunct to DFDBA in Intrabony Defects
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