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NCT03009097
"Comparative Evaluation Of The Efficacy Of Atorvastatin Gel As An Adjunct To Allografts In The Treatment Of Intrabony Defects" - A Clinico Radiological Study
Phase 4 trial testing DFDBA in Chronic Periaortitis in 26 participants. Completed in 1 August 2014.
1 August 2014
Quick facts
| Lead sponsor | Kamineni Institute of Dental Sciences |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 1 April 2013 |
| Primary completion | 1 August 2014 |
| Estimated completion | 1 August 2014 |
Drugs / interventions tested
- DFDBA — full drug profile →
- DFDBA with atorvastatin — full drug profile →
Conditions studied
- Chronic Periaortitis — all drugs for Chronic Periaortitis →
- Intrabony Periodontal Defect — all drugs for Intrabony Periodontal Defect →
Sponsor
Kamineni Institute of Dental Sciences
Who can join
Adults 18 to 55, any sex, with Chronic Periaortitis or Intrabony Periodontal Defect. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
bone fill in mm was measured by taking radiographs
Time frame: 6 months
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03009097
- Europe PMC full search
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Related trials
Other Kamineni Institute of Dental Sciences trials
Trials by the same sponsor.
- NCT03370042 — Single Stage Root Coverage for Gingival Recession With or Without Free Gingival Graft · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03009097 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kamineni Institute of Dental Sciences
- Last refreshed: 3 January 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03009097.
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