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Osteotome-mediated sinus floor elevation using an in situ hardening biphasic calcium phosphate bone graft substitute compared to xenograft: A randomized controlled clinical trial.
Kakar, A, Sripathi Rao, BH, Deshpande, N, Hegde, S, Kohli, A, Patney, A, Mahajan, H
Indian journal of dental research : official publication of Indian Society for Dental Research. 2021;(1):61-68
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AIM: To assess osteotome-mediated sinus floor elevation (OMSFE) with simultaneous implant placement using an in situ hardening biphasic calcium phosphate (BCP) compared to xenograft as a control. METHODS Patient in need for sinus floor augmentation in one or both sinuses were selected for this randomised controlled clinical trial. Sites presenting a residual sinus floor height of 3-6 mm and eligible for OMSFE were randomly assigned to receive either BCP (test) or xenograft particles (control). CBCT scans were performed before and at the time of implant loading (180 days). The difference in sinus floor height gain between the two groups was set as the primary endpoint parameter for equivalence testing. The implant insertion torque (ITV) was recorded and Implant stability quotients (ISQ) was assessed upon implant placement, abutment connection (160 days) and implant loading (180 days). RESULTS A total of 54 sinus lifts were performed in 42 patients including 12 bilateral cases. Four implants failed (two in each group) and a total of six patients were lost to follow-up. Statistical analysis of sinus floor height revealed no significant differences (p < 0.05) between groups at baseline nor at 180 days after augmentation. There was no statistical difference in sinus floor height gain between the two groups as supported by the 90% confidence intervals of the difference between groups. Good primary implant stability was confirmed in both treatment groups by ITV and ISQ measurements. CONCLUSIONS Within the limits of this study, it can be concluded that OMSFE using in situ hardening BCP particles results in equivalent sinus floor height gain than using xenograft particles but offers an easier application.
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A randomized controlled trial evaluating the efficacy of a 67% sodium bicarbonate toothpaste on gingivitis.
Lomax, A, Patel, S, Wang, N, Kakar, K, Kakar, A, Bosma, ML
International journal of dental hygiene. 2017;(4):e35-e41
Abstract
INTRODUCTION In previous studies, toothpastes with high levels of sodium bicarbonate (>50%) have reduced gingival inflammation and oral malodour. This study compared the effects of brushing for 6 weeks with 67% (test group) or 0% (control group) sodium bicarbonate toothpaste on gingival health. METHODS This was a single-centre, single examiner-blind, randomized, controlled, two-treatment, parallel-group study. Eligible subjects (≥18 years) had ≥20 gradable teeth, mild-to-moderate gingivitis, a positive response to bleeding on brushing and ≥20 bleeding sites. The primary objective was to compare the number of bleeding sites following twice-daily use of 67% sodium bicarbonate toothpaste or 0% sodium bicarbonate toothpaste after 6 weeks. Secondary endpoints included Modified Gingival Index (MGI), Bleeding Index (BI) and volatile sulphur compounds (VSC), assessed after 6 weeks. Safety was assessed by treatment-emergent oral soft tissue abnormalities and adverse events. RESULTS Of 148 patients randomized (74 to each treatment), 66 (89.2%) completed the study in the test group, compared with 69 (93.2%) in the control group. Compared with the control group, the test group had a significant reduction in the number of bleeding sites at Week 6 (absolute difference - 11.0 [-14.0, -8.0], P < 0.0001; relative difference - 25.4%), together with significant reductions in MGI and BI (both P < 0.0001). Although the median reductions from baseline for VSC were numerically greater in the test group, the difference did not reach statistical significance (P = 0.9701). CONCLUSIONS This 67% sodium bicarbonate toothpaste provided statistically significant improvements in gingival health and bleeding after 6 weeks of use.
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A randomized placebo-controlled trial of the efficacy of denosumab in Indian postmenopausal women with osteoporosis.
Pitale, S, Thomas, M, Rathi, G, Deshmukh, V, Kumar, P, Reddy, S, Shetty, N, Kakar, A, Babhulkar, S, Mody, B, et al
Indian journal of endocrinology and metabolism. 2015;(1):148-54
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INTRODUCTION Osteoporosis is a serious condition affecting up to 50% of Indian postmenopausal women. Denosumab reduces bone resorption by targeting the receptor activator of nuclear factor-κB ligand. This study assessed the efficacy and safety of denosumab in Indian postmenopausal women with osteoporosis. MATERIALS AND METHODS In this double-blind, multicenter, phase 3 study, 250 Indian postmenopausal women aged 55 to 75 years (T-score <-2.5 and >-4.0 at the lumbar spine or total hip; serum 25(OH) D levels ≥20 ng/mL) were randomized to receive one subcutaneous dose of denosumab 60 mg or placebo. All subjects received oral calcium ≥1000 mg and vitamin D3 ≥ 400 IU daily. The primary end point was mean percent change in bone mineral density (BMD) at the lumbar spine from baseline to Month 6. Secondary end points included mean percent change from baseline in BMD at total hip, femoral neck, and trochanter at Month 6 and median percent change from baseline in bone turnover markers at Months 1, 3, and 6. RESULTS Total 225 subjects (denosumab = 111, placebo = 114) completed the six-month study. Baseline demographics were similar between groups. A 3.1% (95% confidence interval, 1.9%, 4.2%) increase favoring denosumab versus placebo was seen for the primary end point (P < 0.0001). Denosumab demonstrated a significant treatment benefit over placebo for the secondary end points. There were no fractures or withdrawals due to adverse events. CONCLUSIONS Consistent with results from studies conducted in other parts of the world, denosumab was well tolerated and effective in increasing BMD and decreasing bone turnover markers over a six-month period in Indian postmenopausal women.
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A randomised clinical trial to assess maintenance of gingival health by a novel dentifrice containing 0.1%w/w o-cymen-5-ol and 0.6%w/w zinc chloride.
Kakar, A, Newby, EE, Kakar, K, Ghosh, S, Targett, D, Bosma, ML
International dental journal. 2011;(Suppl 3):13-20
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OBJECTIVES To assess the ability of 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride dentifrice to maintain gingival health compared to a sodium fluoride control dentifrice. DESIGN Following a baseline examination, subjects went through a regimen to bring them to a high level of gingival health. This included a professional prophylaxis supported by oral hygiene instruction prior to commencing study treatment. Subjects brushed twice daily for 12 weeks with either the test or control dentifrice. Examinations for gingival inflammation (MGI), bleeding and plaque were performed after 6 and 12 weeks. RESULTS 224 subjects were included in the efficacy analysis. Relative to the sodium fluoride/ silica control dentifrice group the o-cymen-5-ol/ zinc chloride dentifrice exhibited statistically significant reductions (p<0.0001) in MGI, bleeding and plaque of 12.3%, 18.5% and 13.2% respectively after six weeks and 38.1%, 37.8% and 24.2% after 12 weeks. CONCLUSION The results of the present clinical study demonstrate that the use of the 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride dentifrice over a 12 week period provides a statistically significant benefit in maintaining gingival health compared to a sodium fluoride control dentifrice.
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A randomised clinical trial to assess maintenance of gingival health by a novel gel to foam dentifrice containing 0.1%w/w o-cymen-5-ol, 0.6%w/w zinc chloride.
Kakar, A, Newby, EE, Ghosh, S, Butler, A, Bosma, ML
International dental journal. 2011;(Suppl 3):21-7
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OBJECTIVES To assess the ability of 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride gel to foam dentifrice to maintain gingival health compared to a sodium fluoride control dentifrice. DESIGN Following a baseline examination, subjects went through a regimen to bring them to a high level of gingival health. This involved a professional dental prophylaxis supported by oral hygiene instruction prior to commencing study treatment. Subjects brushed twice daily for 12 weeks with either the test or control dentifrice. Examinations for gingival inflammation (MGI), bleeding and plaque were performed after 12 weeks. RESULTS 205 subjects were included in the efficacy analysis. Relative to the sodium fluoride/ silica control dentifrice group the o-cymen-5-ol/ zinc chloride gel to foam dentifrice exhibited statistically significant reductions (p<0.0001) in MGI, bleeding and plaque of 32.2%, 26.3% and 20.7% respectively after 12 weeks. CONCLUSION The results of the present clinical study demonstrate that the use of the 0.1%w/w o-cymen-5-ol/ 0.6%w/w zinc chloride gel to foam dentifrice over a 12 week period provides a statistically significant benefit in maintaining gingival health compared to a sodium fluoride control dentifrice.