Universal Adhesives and Adhesion Modes in Non-Carious Cervical Restorations: 2-Year Randomised Clinical Trial

This prospective, double-blind, six-arm parallel randomised controlled trial aimed to compare the performance of two universal adhesives (UAs) in non-carious cervical lesions (NCCLs), using the FDI criteria, and analysed if participants/NCCLs’ characteristics influenced the outcome. Thirty-eight 18- to 65-year-old participants were seeking routine dental care at a university clinic. At baseline, 210 NCCLs were randomly allocated to six groups (35 restorations’ each). The UAs tested were FuturabondU (FBU) and AdheseUniversal (ADU) applied in either etch-and-rinse (ER) and self-etch (SE) modes. FuturabondDC (FBDC) in SE and in SE with selective enamel etching (SE-EE) modes were controls. NCCLs were restored with AdmiraFusion. The analysis included nonparametric tests, Kaplan-Meier and log-rank tests (α = 0.05). At 2-years, of 191 restorations, ten were missed due to retention loss (all groups, p > 0.05). FBDC (p = 0.037) and FBU (p = 0.041) performed worse than ADU in SE mode. FBDC and FBU also showed worse functional success rate (p = 0.012, p = 0.007, respectively) and cumulative retention rates (p = 0.022, p = 0.012, respectively) than ADU. Some participants/NCCLs’ characteristics influenced (p < 0.05) the outcomes. FBU did not perform as well as ADU, especially in SE mode and due to functional properties. Participants’ age and NCCLs’ degree of dentin sclerosis and internal shape angle influenced FBU performance.

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Can topical epinephrine application to the papilla prevent pancreatitis after endoscopic retrograde cholangiopancreatography? Results from a double blind, multicentre, placebo controlled, randomised clinical trial

BMJ Open Gastroenterology ◽

10.1136/bmjgast-2020-000562 ◽

2021 ◽

Vol 8 (1) ◽

pp. e000562

Author(s):

Adriana Fabiola Romano-Munive ◽

J Jesus García-Correa ◽

Luis F García-Contreras ◽

José Ramírez-García ◽

Luis Uscanga ◽

...

Keyword(s):

Endoscopic Retrograde Cholangiopancreatography ◽

Controlled Trial ◽

Randomised Clinical Trial ◽

Sterile Water ◽

Endoscopic Retrograde ◽

Double Blind ◽

Registration Number ◽

Baseline Characteristics ◽

Randomised Controlled ◽

Rectal Indomethacin

Background and study aimsPost-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a complication associated with important morbidity, occasional mortality and high costs. Preventive strategies are suboptimal as PEP continues to affect 4% to 9% of patients. Spraying epinephrine on the papilla may decrease oedema and prevent PEP. This study aimed to compare rectal indomethacin plus epinephrine (EI) versus rectal indomethacin plus sterile water (WI) for the prevention of PEP.Patients and methodsThis multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 mL of sterile water or a 1:10 000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure. The trial was stopped half way through after a new publication reported an increased incidence of PEP among patients receiving epinephrine.ResultsOf the 3602 patients deemed eligible, 3054 were excluded after screening. The remaining 548 patients were randomised to EI group (n=275) or WI group (n=273). The EI and WI groups had similar baseline characteristics. Patients in the EI group had a similar incidence of PEP to those in the WI group (3.6% (10/275) vs 5.12% (14/273), p=0.41). Pancreatic duct guidewire insertion was identified as a risk factor for PEP (OR 4.38, 95% CI (1.44 to 13.29), p=0.009).ConclusionSpraying epinephrine on the papilla was no more effective than rectal indomethacin alone for the prevention of PEP.Trial registration numberThis study was registered with ClinicalTrials.gov (NCT02959112).

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Onset of analgesia by a topically administered flurbiprofen lozenge: a randomised controlled trial using the double stopwatch method

British Journal of Pain ◽

10.1177/2049463718756152 ◽

2018 ◽

Vol 12 (4) ◽

pp. 208-216 ◽

Cited By ~ 3

Author(s):

Bernard Schachtel ◽

Sue Aspley ◽

Adrian Shephard ◽

Emily Schachtel ◽

Mary Beth Lorton ◽

...

Keyword(s):

Pain Relief ◽

Sore Throat ◽

Median Time ◽

Controlled Trial ◽

Moderate Intensity ◽

Onset Of Action ◽

Serious Adverse Events ◽

Double Blind ◽

Kaplan Meier ◽

Randomised Controlled

Background: The double stopwatch (DSW) method for determining the onset of analgesic activity has been implemented extensively by investigators studying orally administered drugs. Objective: The aim of this randomised, placebo-controlled trial was to use the DSW method to determine the time to onset of analgesia of a single dose of a topically administered non-steroidal anti-inflammatory drug, flurbiprofen 8.75 mg lozenge. Methods: Adults with acute sore throat (n = 122) were examined to confirm the presence of tonsillopharyngitis (Tonsillo-Pharyngitis Assessment) and sore throat pain of at least moderate intensity (≥6 on a 0–10 Sore Throat Scale). Lozenges containing flurbiprofen 8.75 mg or inert ingredients (identically flavoured) were administered under double-blind conditions in the clinic while patients assessed pain and pain relief over 3 hours. Onset of analgesia was determined using the DSW method and reported as the Kaplan–Meier median time to meaningful relief. The median time to first perceived relief was also documented. Results: About 78% of flurbiprofen-treated patients reported meaningful pain relief compared with 48% of placebo-treated patients (p < 0.01); median time to meaningful relief for flurbiprofen-treated patients was 43 minutes (placebo-treated patients were right-censored due to non-responsivity; p = 0.01). Median time to first perceived pain relief was 11 minutes for flurbiprofen-treated patients and 19 minutes for placebo-treated patients (p = 0.03). Flurbiprofen lozenge was well tolerated, with no serious adverse events occurring and no patient discontinuing due to an adverse event. Conclusion: These results indicate that the DSW method can be successfully applied to the evaluation of the onset of action of a locally administered analgesic in patients with acute sore throat, demonstrating that the onset of action (time to meaningful pain relief) of flurbiprofen lozenge was <45 minutes.

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Alternative Caries Management Options for Primary Molars: 2.5-Year Outcomes of a Randomised Clinical Trial

Caries Research ◽

10.1159/000477855 ◽

2017 ◽

Vol 51 (6) ◽

pp. 605-614 ◽

Cited By ~ 35

Author(s):

Ruth M. Santamaría ◽

N.P.T. Innes ◽

Vita Machiulskiene ◽

Julian Schmoeckel ◽

Mohammad Alkilzy ◽

...

Keyword(s):

Controlled Trial ◽

Survival Rates ◽

Randomised Clinical Trial ◽

Primary Molars ◽

Management Options ◽

Kaplan Meier ◽

Significant Difference ◽

Caries Management ◽

Caries Removal ◽

Randomised Controlled

Less invasive caries management techniques for treating cavitated carious primary teeth, which involve the concept of caries control by managing the activity of the biofilm, are becoming common. This study aimed to compare the clinical efficacy (minor/major failures) and survival rates (successful cases without any failures) of 3 carious lesion treatment approaches, the Hall Technique (HT), non-restorative caries treatment (NRCT), and conventional restorations (CR), for the management of occlusoproximal caries lesions (ICDAS 3-5) in primary molars. Results at 2.5 years are presented. A total of 169 children (3- to 8-year-olds) were enrolled in this secondary care-based, 3-arm parallel-group, randomised controlled trial. Participants were allocated to: HT (n = 52; sealing caries with stainless-steel crowns without caries removal), NRCT (n = 52; opening up the cavity and applying fluoride varnish), CR (n = 65; control arm, complete caries removal and compomer restoration). Statistical analyses were: non-parametric Kruskal-Wallis analysis of variance, Mann-Whitney U test and Kaplan-Meier survival analyses. One hundred and forty-two participants (84%; HT = 40/52; NRCT = 44/52; CR = 58/65) had follow-up data of 1-33 months (mean = 26). Overall, 25 (HT = 2, NRCT = 9, CR = 14) of 142 participants (17.6%) presented with at least 1 minor failure (reversible pulpitis, caries progression, or secondary caries; p = 0.013, CI = 0.012-0.018; Mann-Whitney U test). Ten (HT = 1, NRCT = 4, CR = 5) of 142 participants (7.04%) experienced at least 1 major failure (irreversible pulpitis, abscess, unrestorable tooth; p = 0.043, CI = 0.034-0.045). Independent comparisons between 2 samples found that NRCT-CR had no statistically significant difference in failures (p > 0.05), but for CR-HT (p = 0.037, CI = 0.030-0.040) and for NRCT-HT (p = 0.011, CI = 0.010-0.016; Kruskal-Wallis test) significant differences were observed. Cumulative survival rates were HT = 92.5%, NRCT = 70.5%, and CR = 67.2% (p = 0.012). NRCT and CR outcomes were comparable. HT performed better than NRCT and CR for all outcomes. This study was funded by the Paediatric Dentistry Department, Greifswald University, Germany (Trial registration No. NCT01797458).

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