| 1. |
- Isacsson, Göran, et al.
(författare)
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Use of bibloc and monobloc oral appliances in obstructive sleep apnoea : a multicentre, randomized, blinded, parallel-group equivalence trial
- 2019
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Ingår i: European Journal of Orthodontics. - : Oxford University Press. - 0141-5387 .- 1460-2210. ; 41:1, s. 80-88
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Tidskriftsartikel (refereegranskat)abstract
- Background: The clinical benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that the two types of appliances are equally effective in treating OSA.Objective: To compare the efficacy of monobloc versus bibloc appliances in a short-term perspective.Patients and methods: In this multicentre, randomized, blinded, controlled, parallel-group equivalence trial, patients with OSA were randomly assigned to use either a bibloc or a monobloc appliance. One-night respiratory polygraphy without respiratory support was performed at baseline, and participants were re-examined with the appliance in place at short-term follow-up. The primary outcome was the change in the apnoea-hypopnea index (AHI). An independent person prepared a randomization list and sealed envelopes. Evaluating dentist and the biomedical analysts who evaluated the polygraphy were blinded to the choice of therapy.Results: Of 302 patients, 146 were randomly assigned to use the bibloc and 156 the monobloc device; 123 and 139 patients, respectively, were analysed as per protocol. The mean changes in AHI were -13.8 (95% confidence interval -16.1 to -11.5) in the bibloc group and -12.5 (-14.8 to -10.3) in the monobloc group. The difference of -1.3 (-4.5 to 1.9) was significant within the equivalence interval (P = 0.011; the greater of the two P values) and was confirmed by the intention-to-treat analysis (P = 0.001). The adverse events were of mild character and were experienced by similar percentages of patients in both groups (39 and 40 per cent for the bibloc and monobloc group, respectively).Limitations: The study shows short-term results with a median time from commencing treatment to the evaluation visit of 56 days and long-term data on efficacy and harm are needed to be fully conclusive.Conclusion: In a short-term perspective, both appliances were equivalent in terms of their positive effects for treating OSA and caused adverse events of similar magnitude.Trial registration: Registered with ClinicalTrials.gov (#NCT02148510).
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| 2. |
- Adern, Bengt, et al.
(författare)
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Self-reportance of temporomandibular disorders in adult patients attending general dental practice in Sweden from 2011 to 2013
- 2018
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Ingår i: Acta Odontologica Scandinavica. - : Taylor & Francis. - 0001-6357 .- 1502-3850. ; 76:7, s. 530-534
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The study aim was to evaluate the prevalence of self-reported temporomandibular disorders (TMD) and acceptance or nonacceptance of such disorders in adult patients attending all public dental health services in the County of Sormland, Sweden, during a 3-year period, 2011-2013. Methods: Two questions were asked about TMD and the voluntary mouth-opening capacity was measured. The results were registered in a score 0-3. The registration was completed with a question about each patient's acceptance or nonacceptance of their condition. Results: More than 73,000 registrations of the TMD condition were performed in general dental clinics from 2011 to 2013. The mean prevalence of a TMD score of 1-3 was 5% and was consistent over these years. Seventy percent of these patients were women. The peak prevalence of TMD was registered in patients aged 30-45years (38%), and the frequency declined in older age groups. Reduced voluntary mouth-opening capacity (<= 35 mm) was found in less than 2% of the participants. About one-fifth of the patients with a TMD-score of 1-3 did not accept their condition and wanted professional care. The frequency of nonacceptance of the condition increased with the severity of symptom score: 15%, 27%, and 49% for scores 1, 2, and 3, respectively. Conclusions: This study shows that the prevalence of self-reported TMD in adult patients was consistent from 2011 to 2013 and should be considered as a public health issue in Sweden. Patients with more severe TMD pain symptoms wanted care more frequent. The annual clinical calibrations should be continued to achieve an acceptable level of registration.
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| 3. |
- Feldman, Inna, Docent, 1951-, et al.
(författare)
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Cost-effectiveness of a high-intensity versus a low-intensity smoking cessation intervention in a dental setting : long-term follow-up
- 2019
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Ingår i: BMJ Open. - : BMJ PUBLISHING GROUP. - 2044-6055. ; 9
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The aim of this study was to conduct a cost-effectiveness analysis (CEA) of a high-intensity and a low-intensity smoking cessation treatment programme (HIT and LIT) using long-term follow-up effectiveness data and to validate the cost-effectiveness results based on short-term follow-up.Design and outcome measures: Intervention effectiveness was estimated in a randomised controlled trial as numbers of abstinent participants after 1 and 5-8 years of follow-up. The economic evaluation was performed from a societal perspective using a Markov model by estimating future disease-related costs (in Euro (Euro) 2018) and health effects (in quality-adjusted life-years (QALYs)). Programmes were explicitly compared in an incremental analysis, and the results were presented as an incremental cost-effectiveness ratio.Setting: The study was conducted in dental clinics in Sweden.Participants: 294 smokers aged 19-71 years were included in the study.Interventions: Behaviour therapy, coaching and pharmacological advice (HIT) was compared with one counselling session introducing a conventional self-help programme (LIT).Results: The more costly HIT led to higher number of 6-month continuous abstinent participants after 1 year and higher number of sustained abstinent participants after 5-8 years, which translates into larger societal costs avoided and health gains than LIT. The incremental cost/QALY of HIT compared with LIT amounted to Euro918 and Euro3786 using short-term and long-term effectiveness, respectively, which is considered very cost-effective in Sweden.Conclusion: CEA favours the more costly HIT if decision makers are willing to spend at least Euro4000/QALY for tobacco cessation treatment.
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| 4. |
- Fransson, Anette M. C., 1954-, et al.
(författare)
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The outcome of oral appliance therapy on position-dependent obstructive sleep apnea : A multicenter randomized controlled trial
- 2022
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Ingår i: American Journal of Orthodontics and Dentofacial Orthopedics. - : Elsevier. - 0889-5406 .- 1097-6752. ; 162:3, s. 386-393
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: This multicenter trial on patients with obstructive sleep apnea (OSA) treated with an oral appliance aimed to determine the effect of sleeping positions.METHODS: A cohort of 314 patients with OSA were enrolled and evaluated at 8 weeks and 1 year, focusing on treatment effects. At baseline and the 2 follow-ups, new polygraphic registration comparing the proportion of treatment responders without position-dependent OSA (non-position-dependent OSA [non-POSA]) and with POSA was used.RESULTS: At the 8-week and 1-year follow-up, 205 and 139 patients were included, respectively. The proportion of responders (apnea-hypopnea index [AHI] <10 and/or ≥50% reduction in AHI) was 56% for the non-POSA group and 69% for the POSA group (not significant [NS]). The responders increased at the 1-year follow-up: 68% and 77% for the non-POSA and POSA groups (NS), respectively. The absolute change in AHI in all sleeping positions at 8 weeks was -12.9 (interquartile range, -25.0 to -0.5) in the non-POSA group and -10.5 (interquartile range, -19.9 to -5.3; NS) in the POSA group. However, the decrease in supine AHI was significantly greater among subjects with POSA. In contrast, the decrease in nonsupine AHI was significantly greater in the non-POSA group, an effect that remained at the 1-year follow-up.CONCLUSIONS: Our hypothesis that subjects with POSA at baseline would have a higher treatment response rate after oral appliance treatment compared with subjects without POSA was rejected. However, those with POSA had a significantly higher supine AHI decrease, and those without POSA had significantly less nonsupine AHI.
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| 5. |
- Hedberg, Pär, et al.
(författare)
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Effects of oral appliance treatment on inflammatory biomarkers in obstructive sleep apnea : A randomised controlled trial
- 2021
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Ingår i: Journal of Sleep Research. - : John Wiley & Sons. - 0962-1105 .- 1365-2869. ; 30:4
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Tidskriftsartikel (refereegranskat)abstract
- Obstructive sleep apnea (OSA) may lead to increased circulating concentrations of inflammatory biomarkers and treatment may change these. We aimed to assess the effect of oral appliance (OA) therapy on inflammatory biomarkers in a randomised controlled pilot trial. A total of 71 patients with OSA and systemic hypertension were randomly allocated to an active, mandible protruded (OAa) or a passive, mandible non-protruded device (OAp) treatment. Serum concentrations of the inflammatory biomarkers white blood cells, high-sensitivity C-reactive protein, interleukin 6, interleukin 10, and tumour necrosis factor-alpha were measured at baseline and after 3 months of OA treatment. The differences between treatment groups in biomarker concentration change during the treatment were presented as the Vargha and Delaney effect size and evaluated with the Wilcoxon-Mann-Whitney test. This effect size expresses the probability of a higher value in a random participant from one group compared with a random patient from the other group, and a value of 0.5 means stochastically equal groups. After 3 months of treatment, there was a significant reduction of the apnea-hypopnea index in the OAa group compared with the OAp group (effect size 0.258, 95% confidence interval 0.146-0.386, p < .001). There were no significant differences between the groups in any of the inflammatory markers' concentration changes during the treatment period (effect sizes between 0.488 and 0.524; all p values >=.737). Thus, OA treatment for 3 months did not affect circulating concentrations of some common inflammatory markers in patients with OSA and systemic hypertension.
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| 6. |
- Isacsson, G., et al.
(författare)
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Bibloc and Monobloc Oral appliances in the Treatment of Obstructive Sleep apnoea : a Multicenter, Randomized, Blinded, Parallel-Group Trial
- 2017
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Ingår i: Sleep Medicine. - : Elsevier. - 1389-9457 .- 1878-5506. ; 40:Suppl 1, s. E142-E143
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Introduction: The clinical benefit of bibloc over monobloc appliances has not been established in randomized trials treating obstructive sleep apnoea (OSA). We hypothesized that the two types of appliances are equally effective in treating moderate to severe OSA. Materials and methods: We performed a blinded, multicenter, randomized, controlled, prospective, parallel-group trial including patients aged 18 years or older who had moderate-to-severe OSA. Patients were randomly assigned to receive either a bibloc or a monobloc appliance with the intention to protrude the mandible 75% of the individual maximal protrusion capacity. At baseline a one-night respiratory polygraphy was done without any respiratory support. The polygraphy was iterated with the appliance in place at a 6-week follow-up. The primary outcome was the absolute change in the apnoea-hypopnea-index (AHI) from baseline to the 6-week follow-up, analysed in the per-protocol population. All patients who received an appliance were included in the safety analysis. This trial is registered with ClinicalTrials.gov, number NCT02148510, and approved by Uppsala Regional Ethical Review Board, Sweden (#2014/021). Results: We recruited patients from three dental specialist clinics in Sweden; enrolment of 302 patients was done between March 2014 and April 2016; 146 randomized to bibloc and 156 to monobloc appliance. Twenty-three patients in the bibloc group and 17 in the monobloc group were withdrawn due to reasons like appliance could not be fitted, lack of compliance, adverse events or non-valid follow-up polygraphy i.e. a per-protocol group of 123 bibloc and 139 monobloc treated patients. The mean change of AHI from baseline to 6 weeks of treatment was -13.8 (95% CI -16.1 to -11.5; p < 0.001) in the bibloc group and -12.5 (95% CI -14.8 to -10.3; p < 0.001) in the monobloc group. The mean difference was not significant between the groups (-1.3 (95% CI -4.5 to 1.9). The most common adverse event in the orofacial region was upper airway infection followed by complains from various parts of the mouth, jaws and teeth. Conclusions: Bibloc and monobloc appliance treatment was equal in their effects in treating OSA as measured by at home polygraphic respiratory measures and the appliances were associated with a similar degree of adverse events. Acknowledgements: Funding from Uppsala-Örebro Regional Research Council and Vastmanland County Council, Sweden.
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| 7. |
- Isacsson, G., et al.
(författare)
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Pain relief following a single-dose intra-articular injection of methylprednisolone in the temporomandibular joint arthralgia-A multicentre randomised controlled trial
- 2019
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Ingår i: J Oral Rehabil. - : Wiley. - 0305-182X .- 1365-2842. ; 46:1, s. 5-13
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Tidskriftsartikel (refereegranskat)abstract
- Background Temporomandibular joint (TMJ) arthralgia is a painful condition assumed to be associated with local inflammation. Objective The objective of the present study was to determine the efficacy for reducing pain of a single-dose intra-articular (IA) injection of methylprednisolone to the TMJ. The hypothesis was that methylprednisolone would effectively reduce TMJ pain. Methods This randomised, double-blind, parallel-group, multicentre, controlled study included visits for enrolment, treatment and 4-week follow-up. The study included patients 18 years and older who had been diagnosed with unilateral TMJ arthralgia. All participants were randomly assigned to receive 1 mL IA injections of methylprednisolone or saline. The primary outcome was change in recorded pain intensity on a visual analogue scale (VAS) at maximum jaw opening, analysed in the per protocol population. Results In total, 54 patients were randomly assigned to single-dose IA injections with methylprednisolone (n = 27) or saline (n = 27). Between baseline and the 4-week follow-up, VAS-rated pain intensity at maximum jaw opening decreased from a mean of 61.0 (95% confidence interval [CI]: 50.1; 70.7) to 33.9 (95% CI: 21.6; 46.2) in the methylprednisolone group and from 59.6 (95% CI: 50.7; 65.9) to 33.9 (95% CI: 23.8; 43.9) in the saline group. The between-group difference was not significant (P = 0.812). Treatment-related adverse events were doubled in the methylprednisolone group. Conclusion Methylprednisolone provided no additional benefit for reducing pain, but caused more harm compared with saline following a single-dose IA injection in patients with TMJ arthralgia.
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| 8. |
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| 9. |
- Malmström, B., et al.
(författare)
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Simulation-based team training improved the self-assessed ability of physicians, nurses and midwives to perform neonatal resuscitation
- 2017
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Ingår i: Acta Paediatrica. - : WILEY. - 0803-5253 .- 1651-2227. ; 106:8, s. 1273-1279
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Tidskriftsartikel (refereegranskat)abstract
- The use of simulation-based team training in neonatal resuscitation has increased in Sweden during the last decade, but no formal evaluation of this training method has been performed. This study evaluated the effect of simulation-based team training on the self-assessed ability of personnel to perform neonatal resuscitation. Methods: We evaluated a full-day simulation-based team training course in neonatal resuscitation, by administering a questionnaire to 110 physicians, nurses and midwives before and after the training period. The questionnaire focused on four important domains: communication, leadership, confidence and technical skills. The study was carried out in Sweden from 2005 to 2007. Results: The response rate was 84%. Improvements in the participants self-assessed ability to perform neonatal resuscitation were seen in all four domains after training (p < 0.001). Professionally inexperienced personnel showed a significant improvement in the technical skills domain compared to experienced personnel (p = 0.001). No differences were seen between professions or time since training in any of the four domains. Personnel with less previous experience with neonatal resuscitation showed improved confidence (p = 0.007) and technical skills (p = 0.003). Conclusion: A full-day course on simulation-based team training with video-supported debriefing improved the participants' self-assessed ability to perform neonatal resuscitation.
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| 10. |
- Nohlert, Eva, 1955-, et al.
(författare)
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Self-perceived ability to cope with stress and depressive mood without smoking predicts successful smoking cessation 12 months later in a quitline setting: a secondary analysis of a randomized trial
- 2018
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Ingår i: BMC Public Health. - : Springer Science and Business Media LLC. - 1471-2458. ; 18
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Tidskriftsartikel (refereegranskat)abstract
- Background: Telephone-based smoking cessation services ('quitlines') are both effective and cost-effective. Knowledge of modifiable baseline factors in real-life settings with heterogeneous participants is essential for the development and improvement of treatment protocols to assist in telephone-based smoking cessation. The aim was to assess if self-perceived abilities to cope measured at baseline, would predict abstinence at the 12-month follow-up at the Swedish National Tobacco Quitline (SNTQ). Methods: The data were retrieved from a previous randomized controlled trial comparing the effectiveness of proactive and reactive service at the SNTQ. Included were 612 clients calling the SNTQ between February 2009 and September 2010. Outcome measures were self-reported point prevalence and 6-month continuous abstinence at the 12-month follow-up. Plausible predictors of smoking cessation were assessed at the first call and in a baseline questionnaire. Self-perceived abilities at baseline were measured by two questions: (1) How likely is it that you will be smoke-free in one year? and (2) How likely are you to be able to handle stress and depressive mood without smoking? The associations between potential predictors and outcome (smoke-free at 12-month follow-up) were assessed by logistic regression analysis. Results: Of the two potential predictors for abstinence at 12-month follow-up, only the perceived ability to handle stress and depressive mood without smoking remained significant in the adjusted analyses (Odds Ratio, OR 1.13, 95% CI 1.00-1.27 for point prevalence and OR 1.16, 95% CI 1.01-1.33 for 6-month continuous abstinence according to intention-to-treat). The overall strongest predictor in the adjusted analyses was smoking status in the week before baseline (OR 3.30, 95% CI 1.79-6.09 for point prevalence and OR 3.97, 95% CI 2.01-7.83 for 6-month continuous abstinence). Conclusions: The perceived ability to handle stress and depressive mood without smoking at baseline predicted the subjects' abstinence at the 12-month follow-up. An assessment of/adjustment for stress and depressive mood coping skills may be appropriate in future smoking cessation treatment and research. The treatment protocol can be tailored to individual differences and needs for optimal support.
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