SRP and Placebo gel
DrugAfter SRP, placebo gel was delivered subgingivally into the pocket
NCT Number: NCT02455869
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of two local drug delivery systems containing 1% ALN gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.
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Notify Me30 year–50 year
All sexes
Interventional
Phase 2 / Phase 3
Background: Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1.2% ATV gel as a local drug delivery system in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.
Methods: A total of 90 intrabony defects were treated with either1%ALN, 1.2% ATV or placebo gel. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth [PD], and clinical attachment level [CAL]) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After SRP, placebo gel was delivered subgingivally into the pocket
After SRP, Atorvastatin gel was delivered subgingivally into the pocket
After SRP, Alendronate gel was delivered subgingivally into the pocket
Time frame: Baseline to 6 months and Baseline to 9 months
Radiographic defect depth reduction to measured at baseline, 6 and 9 months interval
Time frame: 3,6 and 9 months
Plaque index will be measured at 3, 6 and 9 months
Time frame: 3,6 and 9 months]
Modified sulcus bleeding index will be measured at 3, 6 and 9 months
Time frame: 3,6 and 9 months]
Probing pocket depth will be measured at 3, 6 and 9 months
Time frame: 3,6 and 9 months]
Clinical attachment level will be measured at 3, 6 and 9 months
Government Dental College and Research Institute, Bangalore
Other
Comparative Evaluation of Subgingivally Delivered 1% Alendronate Versus 1.2% Atorvastatin Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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