Browsing by Subject "Clinical Trial"

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    Clinical Evaluation of a Universal Adhesive in Non-Carious Cervical Lesions
    (2016) Rouse, Matthew A.; Platt, Jeffrey A.; Jackson, Richard D.; Carlson, Timothy J.; Matis, Bruce A.; Cook, Norman Blaine
    The “total-etch” or “etch-and-rinse” systems have been the gold standard of dental bonding for decades. However, these systems are very technique-sensitive and time-consuming compared to newer “self-etch” or “self-adhesive” systems and have been implicated in cases of postoperative sensitivity. The purpose of this study was to compare the effects of two surface treatment protocols (self-etch vs. selective-etch) on the clinical performance of a universal adhesive and resin composite in Class V non-carious cervical lesions (NCCLs). Thirty-three volunteer subjects (17 male; 16 female; age range = 20 to 75 years) having at least two NCCLs were selected from patients of record at Indiana University School of Dentistry. Each subject received one resin composite restoration (Tetric EvoCeram, Ivoclar Vivadent) utilizing a self-etch (SfE) universal adhesive (Adhese Universal, Ivoclar Vivadent) with no separate enamel etching and another restoration utilizing adhesive and selective enamel etching (SelE) with 37% phosphoric acid (H3PO4). Both the adhesive and composite were placed following the manufacturer’s instructions. The two techniques were compared for differences in sensitivity, retention, marginal discoloration, marginal adaptation, and clinical acceptability at baseline and 6 months using the Cochran-Mantel-Haenszel tests for stratified, ordered categorical outcomes. Seventy-four restorations (37 SfE, 37 SelE) in 30 volunteers were evaluated at 12 months. No significant differences were found between the SfE and SelE groups for any variable at the 12-month recall (p>0.21). Retention was 100% at 12 months for both groups. Marginal adaptation was significantly worse at 12 months than at baseline for SelE (p=0.0163), but there was no difference for SfE (p=0.08). Sensitivity improved significantly from baseline to 12 months for both SelE (p=0.0113) and SfE (p=0.0128). The results obtained from this study are comparable to results observed in similar studies. Like similar studies involving self-etch adhesives in non-carious cervical lesions, our study showed no restorations lost to caries and excellent retention. The deterioration of selective-etch dentin margins was a result that differed from similar studies. A likely explanation for this finding would be the difficulty of controlling precise placement of phosphoric acid gel, causing undesired etching of dentin; this could result in suboptimal bonding to dentin. This report on 12-month data for a two-year study indicates significantly reduced sensitivity for both the SelE and SfE groups, and deterioration of SelE marginal adaptation. No decreases in retention, marginal discoloration, or clinical acceptability were observed in either group.
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    Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study
    (BMJ Journals, 2017-06) Miller Ellis, Eydie; Berlin, Michael S; Ward, Caroline L; Sharpe, John A; Jamil, Alam; Harris, Alon; Ophthalmology, School of Medicine
    Background/aims ONO-9054 is being developed for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) and open-angle glaucoma (OAG). This study compared the novel dual EP3/FP agonist ONO-9054 with the FP agonist Xalatan. Methods Adults (n=123) with bilateral mild/moderate OAG or OHT, with unmedicated IOP of ≥24 mm Hg at 8:00 hours, ≥21 mm Hg at 10:00 hours and ≤36 mm Hg, were randomised 1:1 to receive ONO-9054 (0.003%, 30 μg/mL) or Xalatan (0.005%, 50 μg/mL) once daily for 28 days. Results Day 29 mean diurnal IOP was −7.2 mm Hg for ONO-9054 vs −6.6 mm Hg for Xalatan. At 08:00 hours, the IOPs were comparable, and at all later time points the decrease in IOP was greater for ONO-9054. On day 29, the odds of a mean IOP reduction of ≤−25%, ≤−30% and ≤−35% for ONO-9054 were 2.39, 2.37 and 4.85 times more, respectively, than the odds for Xalatan (p<0.05, post hoc analyses). The percentage of subjects achieving target IOPs on day 29 (≤17, ≤16 and ≤15 mm Hg) was greater for ONO-9054 than for Xalatan; the odds of achieving an IOP ≤15 mm Hg for ONO-9054 were 2.4 times more than the odds for Xalatan (p<0.01, post hoc analysis). Conclusions Subjects randomised to receive ONO-9054 were more likely to achieve a greater per cent reduction in IOP and were more likely to achieve target IOPs than those receiving Xalatan. The effects of ONO-9054 in reducing IOP appear to persist longer than those of Xalatan. Trial registration number NCT02083289, Results.