ABSTRACT
Aim: Four bonding agents and a composite restorative resin were evaluated in patients having noncarious cervical defects. Materials and Methods: This clinical trial was conducted in patients having at least 4 noncarious cervical defects in posterior teeth evaluating the clinical effectiveness in relation to retention, discoloration at margins, and postoperative sensitivity of 5th, 6th, 7th, and 8th generations of bonding agents over a period of baseline, 3, 6, 12, and 24 months. Statistical Analysis: Data were recorded and put into statistical analysis using Chi-square tests. Results: At 24 months, retention rate was found out to be 92.6% for the 7th generation which was better than 5th (66.7%) and 6th (70.4%) generation whereas significant marginal discoloration was seen at 6 months follow-up in which 5th generation showed maximum results. However, all the four generations have an equal score of postoperative sensitivity at all the time intervals. Conclusions: The 7th generation adhesives performed better than other generations in terms of retention. Changes in marginal discoloration were detected at 6 months with maximum score in 5th generation adhesives.
ABSTRACT
A novel corticosteroid compound (short form of IUPAC name: SFDAC) has been discovered by Sun Pharma Advanced Research Company (SPARC) Ltd. A randomized, observer-blind, active-controlled, parallel-groups, intranasal multiple escalating dose study was conducted in healthy male subjects to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of compound SFDAC formulated as an aqueous suspension for intranasal administration. Intranasal sprays of SFDAC, active control fluticasone propionate (FP) and placebo were administered once in a day for 14 days as per randomization. Various clinical evaluations including 24-hour serum cortisol and urinary free cortisol (UFC) profiles were carried out. Blood samples were collected at pre-defined time-points and analyzed using a validated chromatographic method for estimation of SFDAC and its metabolite. The results of the study indicate that multiple dose of SFDAC intranasal spray upto 3,200 µg is safe and tolerated. Clinically significant suppression of hypothalamic pituitary adrenal (HPA) axis was not observed. The plasma concentration of SFDAC was found to be below the lower limit of quantification (LLQ) at most time-points for all subjects. SFDAC M1 metabolite was detected only at picogram level in plasma. The safety and pharmacokinetic characteristics of SFDAC observed in this study support further clinical development of the SFDAC nasal spray.
