Smoking is a key contributor to health inequalities, particularly impacting oral health. Periodontal (gum) health is significantly affected by smoking. With their extensive reach, regular and frequent patient contact, and potential teachable moments, dental teams are well placed to support patients to stop smoking. This is currently mainly provided through Very Brief Advice (VBA) interventions and so there is scope to enhance the cessation support offered. A large definitive trial is needed to confirm whether this would lead to improved smoking quit rates, improved oral health, and be good value for money. The ENHANCE-D trial is a multi-centre, pragmatic, definitive, 3-arm, parallel group, individually randomised controlled superiority trial, including an internal pilot, conducted in NHS dental settings. In total, 1215 patients who are current regular smokers will be randomly allocated using a 1:2:2 ratio to the following: (i) VBA; (ii) the offer of a standard course of Nicotine Replacement Therapy (NRT); (iii) or the offer of an e-cigarette starter kit. A subgroup of patients with periodontitis (gum disease) will have additional oral examinations and samples collected. The primary outcome is biochemically verified smoking abstinence at 6 months. A key secondary outcome is the percentage of periodontal sites with probing pocket depths (PPDs) ≥ 5 mm at 6 months in the periodontitis subgroup. Participants will be blinded to the purpose of the trial and not be aware of the treatment packages. Periodontal health outcomes will be recorded by trained and aligned assessors, blinded to intervention arm. Participant recruitment started in July 2022 with an internal pilot progressing to the main trial in May 2023. A qualitative process evaluation will explore participants’ experiences of receiving the study interventions, alongside the views of dental teams, NHS commissioners, service managers, and policymakers. An economic evaluation will include a cost-effectiveness analysis and a cost–benefit analysis. This will be the largest contemporary randomised trial of smoking cessation interventions in dental settings and one of the first to evaluate enhanced interventions. E-cigarettes were included as an intervention due to growing evidence of their effectiveness. They will be compared to VBA and NRT, and oral health outcomes assessed. The multi-centre, pragmatic design of this trial supports the external validity and potential for impacting clinical practice. ISRCTN 13158982. Registered on 10 May 2022. https://www.isrctn.com/ISRCTNISRCTN13158982

BackgroundSmoking continues to be the single largest cause of preventable disease and death and a major contributor to health inequalities. Dental professionals are well placed to offer behavioural support in combination with pharmacotherapy to increase smoking cessation rates across the population. We aimed to assess the trends and socioeconomic inequalities in the dental attendance of adult smokers in Scotland from 2009 to 2019 and examine the potential population reach of dental settings for smoking cessation interventions.MethodsA secondary analysis was conducted of combined Scottish Health Surveys (SHeS) from 2009/11, 2013/15 and 2017/19. 'Recent' dental attendance (within the past two years) was the focus and descriptive analysis examined attendance of self-reported smokers compared to non-smokers and stratified by the area-based Scottish Index of Multiple Deprivation (SIMD) and individual socioeconomic measures (income, education, and occupation). Generalised linear models were used to model recent attendance in non-smokers relative to smokers adjusted by the socioeconomic measures, for each of the survey cohorts separately. Absolute differences and risk ratios were calculated with 95% Confidence Intervals (CI).ResultsRecent dental attendance was generally high and increased in both smokers (70-76%) and non-smokers (84-87%) from 2009/11 to 2017/19 and increased across all SIMD groups. After adjustment for sociodemographic variables, the adjusted Risk Difference (aRD) for recent attendance between non-smokers and smokers was 8.9% (95% CI 4.6%, 13.2%) by 2017/19. Within smokers, recent attendance was 7-9% lower in those living in the most deprived areas compared to those living in the least deprived areas over the three surveys.ConclusionsSHeS data from 2009 to 2019 demonstrated that a high and increasing proportion of smokers in the population attend the dentist, albeit slightly less frequently than non-smokers. There were large inequalities in the dental attendance of smokers, to a lesser extent in non-smokers, and these persisted over time. Dental settings provide a good potential opportunity to deliver population-level smoking cessation interventions, but smokers in the most deprived groups and older age groups may be harder to reach. Consideration should be given to ensure that these groups are given appropriate proportionate support to take up preventive interventions.

Background The motor speech disorder, dysarthria, is common in cerebral palsy. The Speech Systems Approach therapy programme, which focuses on controlling breath supply and speech rate, has increased children’s intelligibility. Objective To ascertain if increased intelligibility is due to better differentiation of the articulation of individual consonants in words spoken in isolation and in connected speech. Design Secondary analysis. Setting University. Participants Forty-two children with cerebral palsy and dysarthria aged 5–18 years, Gross Motor Function Classification System I–V. Intervention The Speech Systems Approach is a motor learning therapy delivered to individuals by a speech and language therapist in 40-minute sessions, three times per week for 6 weeks. Intervention focuses on production of a strong, clear voice and speaking at a steady rate. Practice changes from single words to increasingly longer utterances in tasks with increasing cognitive load. Main outcome measures Unfamiliar listeners’ identification of singleton consonants (e.g. nap) and clusters of consonants (e.g. stair, end) at the start and end of words when hearing single words in forced choice tasks and connected speech in free transcription tasks. Acoustic measures of sound intensity and duration. Data sources Data collected at 1-week pre- and 1-week post-therapy from three studies: two interrupted time series design, one feasibility randomised controlled trial. Results Word initial and word final singleton consonants and consonant clusters were better identified post-therapy. The extent of improvement differed across word initial and word final singleton consonant subtypes. Improvement was greater for single words than connected speech. Change in sound identification varied across children, particularly in connected speech. Sound intensity and duration increases also were inconsistent. Limitations The small sample size did not allow for analysis of cerebral palsy type. Acoustic data were not available for all children, limiting the strength of conclusions that can be drawn. The different but phonetically balanced word lists, used in the original research, created variability in single words spoken across recordings analysed. Low frequencies of plosives, fricatives and affricates necessitated their combination for analysis preventing investigation of the effect of specific consonants. Connected speech was spontaneous, again creating variability within the data analysed. The estimated effects of therapy may therefore be partially explained by differences in the spoken language elicited. Conclusions The Speech Systems Approach helped children generate greater breath supply and a steady rate, leading to increased intensity and duration of consonant sounds in single words, thereby aiding their identification by listeners. Transfer of the motor behaviour to connected speech was inconsistent. Future work Refining the Speech Systems Approach to focus on connected speech early in the intervention. Personalisation of cues according to perceptual and acoustic speech measures. Creation of a battery of measures that can be repeated across children and multiple recordings. Study registration This trial is registered as Research Registry 6117. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation programme (NIHR130967) and will be published in full in Efficacy and Mechanism Evaluation; Vol. 10, No. 4. See the NIHR Journals Library website for further project information.

Background: Oral mucositis is a debilitating and painful complication of head and neck cancer irradiation that is characterised by inflammation of the mucous membranes, erythema and ulceration. Oral mucositis affects 6000 head and neck cancer patients per year in England and Wales. Current treatments have not proven to be effective. International studies suggest that low-level laser therapy may be an effective treatment. Objectives: To assess the clinical effectiveness and cost-effectiveness of low-level laser therapy in the management of oral mucositis in head and neck cancer irradiation. To identify barriers to and facilitators of implementing low-level laser therapy in routine care. Design: Placebo-controlled, individually randomised, multicentre Phase III superiority trial, with an internal pilot and health economic and qualitative process evaluations. The participants, outcome assessors and therapists were blinded. Setting: Nine NHS head and neck cancer sites in England and Wales. Participants: A total of 87 out of 380 participants were recruited who were aged ≥ 18 years and were undergoing head and neck cancer irradiation with ≥ 60 Gy. Intervention: Random allocation (1 : 1 ratio) to either low-level laser therapy or sham low-level laser therapy three times per week for the duration of irradiation. The diode laser had the following specifications: wavelength 660 nm, power output 75 mW, beam area 1.5 cm2, irradiance 50 mW/cm2, exposure time 60 seconds and fluence 3 J/cm2. There were 20–30 spots per session. Sham low-level laser therapy was delivered in an identical manner. Main outcome measure: The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks following the start of irradiation. Higher scores indicate a worse outcome. Results: A total of 231 patients were screened and, of these, 87 were randomised (low-level laser therapy arm, n = 44; sham arm, n = 43). The mean age was 59.4 years (standard deviation 8.8 years) and 69 participants (79%) were male. The mean Oral Mucositis Weekly Questionnaire-Head and Neck Cancer score at 6 weeks was 33.2 (standard deviation 10) in the low-level laser therapy arm and 27.4 (standard deviation 13.8) in the sham arm. Limitations: The trial lacked statistical power because it did not meet the recruitment target. Staff and patients willingly participated in the trial and worked hard to make the LiTEFORM trial succeed. However, the task of introducing, embedding and sustaining new low-level laser therapy services into a complex care pathway proved challenging. Sites could deliver low-level laser therapy to only a small number of patients at a time. The administration of low-level laser therapy was viewed as straightforward, but also time-consuming and sometimes uncomfortable for both patients and staff, particularly those staff who were not used to working in a patient’s mouth. Conclusions: This trial had a robust design but lacked power to be definitive. Low-level laser therapy is relatively inexpensive. In contrast with previous trials, some patients found low-level laser therapy sessions to be difficult. The duration of low-level laser therapy sessions is, therefore, an important consideration. Clinicians experienced in oral cavity work most readily adapt to delivering low-level laser therapy, although other allied health professionals can be trained. Blinding the clinicians delivering low-level laser therapy is feasible. There are important human resource, real estate and logistical considerations for those setting up low-level laser therapy services. Future work: Further well-designed randomised controlled trials investigating low-level laser therapy in head and neck cancer irradiation are needed, with similar powered recruitment targets but addressing the recruitment challenges and logistical findings from this research. Trial registration: This trial is registered as ISRCTN14224600. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 46. See the NIHR Journals Library website for further project information.

Background Mitochondrial disease is a heterogenous group of rare, complex neurometabolic disorders. Despite their individual rarity, collectively mitochondrial diseases represent the most common cause of inherited metabolic disorders in the UK; they affect 1 in every 4300 individuals, up to 15,000 adults (and a similar number of children) in the UK. Mitochondrial disease manifests multisystem and isolated organ involvement, commonly affecting those tissues with high energy demands, such as skeletal muscle. Myopathy manifesting as fatigue, muscle weakness and exercise intolerance is common and debilitating in patients with mitochondrial disease. Currently, there are no effective licensed treatments and consequently, there is an urgent clinical need to find an effective drug therapy. Aim To investigate the efficacy of 12-week treatment with acipimox on the adenosine triphosphate (ATP) content of skeletal muscle in patients with mitochondrial disease and myopathy. Methods AIMM is a single-centre, double blind, placebo-controlled, adaptive designed trial, evaluating the efficacy of 12 weeks’ administration of acipimox on skeletal muscle ATP content in patients with mitochondrial myopathy. Eligible patients will receive the trial investigational medicinal product (IMP), either acipimox or matched placebo. Participants will also be prescribed low dose aspirin as a non-investigational medical product (nIMP) in order to protect the blinding of the treatment assignment. Eighty to 120 participants will be recruited as required, with an interim analysis for sample size re-estimation and futility assessment being undertaken once the primary outcome for 50 participants has been obtained. Randomisation will be on a 1:1 basis, stratified by Fatigue Impact Scale (FIS) (dichotomised as < 40, ≥ 40). Participants will take part in the trial for up to 20 weeks, from screening visits through to follow-up at 16 weeks post randomisation. The primary outcome of change in ATP content in skeletal muscle and secondary outcomes relating to quality of life, perceived fatigue, disease burden, limb function, balance and walking, skeletal muscle analysis and symptom-limited cardiopulmonary fitness (optional) will be assessed between baseline and 12 weeks. Discussion The AIMM trial will investigate the effect of acipimox on modulating muscle ATP content and whether it can be repurposed as a new treatment for mitochondrial disease with myopathy. Trial registration EudraCT2018-002721-29 . Registered on 24 December 2018, ISRCTN 12895613. Registered on 03 January 2019, https://www.isrctn.com/search?q=aimm

Background A three-arm parallel group, randomised controlled trial set in general dental practices in England, Scotland, and Wales was undertaken to evaluate three strategies to manage dental caries in primary teeth. Children, with at least one primary molar with caries into dentine, were randomised to receive Conventional with best practice prevention (C + P), Biological with best practice prevention (B + P), or best practice Prevention Alone (PA). Methods Data on costs were collected via case report forms completed by clinical staff at every visit. The co-primary outcomes were incidence of, and number of episodes of, dental pain and/or infection avoided. The three strategies were ranked in order of mean cost and a more costly strategy was compared with a less costly strategy in terms of incremental cost-effectiveness. Costs and outcomes were discounted at 3.5%. Results A total of 1144 children were randomised with data on 1058 children (C + P n = 352, B + P n = 352, PA n = 354) used in the analysis. On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36 months. Managing children in PA was, on average, £19 (97.5% CI: -£18 to £55) less costly than managing those in B + P. In terms of effectiveness, on average, there were fewer incidences of, (− 0.06; 97.5% CI: − 0.14 to 0.02) and fewer episodes of dental pain and/or infection (− 0.14; 97.5% CI: − 0.29 to 0.71) in B + P compared to PA. C + P was unlikely to be considered cost-effective, as it was more costly and less effective than B + P. Conclusions The mean cost of a child avoiding any dental pain and/or infection (incidence) was £330 and the mean cost per episode of dental pain and/or infection avoided was £130. At these thresholds B + P has the highest probability of being considered cost-effective. Over the willingness to pay thresholds considered, the probability of B + P being considered cost-effective never exceeded 75%. Trial registration The trial was prospectively registered with the ISRCTN (reference number ISRCTN77044005 ) on the 26th January 2009 and East of Scotland Research Ethics Committee provided ethical approved (REC reference: 12/ES/0047).

Abstract Background There has been comparatively little patient information about bronchiectasis, a chronic lung disease with rising prevalence. Patients want more information, which could improve their understanding and self-management. A novel information resource meeting identified needs has been co-developed in prior work. We sought to establish the feasibility of conducting a multi-centre randomised controlled trial to determine effect of the information resource on understanding, self-management and health outcomes. Methods/design We conducted an unblinded, single-centre, randomised controlled feasibility trial with two parallel groups (1:1 ratio), comparing a novel patient information resource with usual care in adults with bronchiectasis. Integrated qualitative methods allowed further evaluation of the intervention and trial process. The setting was two teaching hospitals in North East England. Participants randomised to the intervention group received the information resource (website and booklet) and instructions on its use. Feasibility outcome measures included willingness to enter the trial, in addition to recruitment and retention rates. Secondary outcome measures (resource use and satisfaction, quality of life, unscheduled healthcare presentations, exacerbation frequency, bronchiectasis knowledge and lung function) were recorded at baseline, 2 weeks and 12 weeks. Results Sixty-two participants were randomised (control group = 30; intervention group = 32). Thirty-eight (61%) were female, and the participants’ median age was 65 years (range 15–81). Median forced expiratory volume in 1 s percent predicted was 68% (range 10–120). Sixty-two of 124 (50%; 95% CI, 41–59%) of potentially eligible participants approached were recruited. Sixty (97%) of 62 participants completed the study (control group, 29 of 30 [97%]; 95% CI, 83–99%; 1 unrelated death; intervention group, 31 [97%] of 32; 95% CI, 84–99%; 1 withdrawal). In the intervention group, 27 (84%) of 32 reported using the information provided, and 25 (93%) of 27 of users found it useful, particularly the video content. Qualitative data analysis revealed acceptability of the trial and intervention. Web analytics recorded over 20,000 page views during the 16-month study period. Conclusion The successful recruitment process, high retention rate and study form completion rates indicate that it appears feasible to conduct a full trial based on this study design. Worldwide demand for online access to the information resource was high. Trial registration ISRCTN Registry, ISRCTN84229105 . Registered on 25 July 2014.

This multicenter 3-arm, parallel-group, patient-randomized controlled trial compared clinical effectiveness of 3 treatment strategies over 3 y for managing dental caries in primary teeth in UK primary dental care. Participants aged 3 to 7 y with at least 1 primary molar with dentinal carious lesion were randomized across 3 arms (1:1:1 via centrally administered system with variable-length random permuted blocks): C+P, conventional carious lesion management (complete carious tooth tissue removal and restoration placement) with prevention; B+P, biological management (sealing in carious tooth tissue restoratively) with prevention; and PA, prevention alone (diet, plaque removal, fluorides, and fissure sealants). Parents, children, and dentists were not blind to allocated arm. Co-primary outcomes were 1) the proportion of participants with at least 1 episode of dental pain and/or infection and 2) the number of episodes of dental pain and/or infection during follow-up (minimum, 23 mo). In sum, 1,144 participants were randomized (C+P, n = 386; B+P, n = 381; PA, n = 377) by 72 general dental practitioners, of whom 1,058 (C+P, n = 352; B+P, n = 352; PA, n = 354) attended at least 1 study visit and were included in the primary analysis. The median follow-up was 33.8 mo (interquartile range, 23.8 to 36.7). Proportions of participants with at least 1 episode of dental pain and/or infection were as follows: C+P, 42%; B+P, 40%; PA, 45%. There was no evidence of a difference in incidence of dental pain and/or infection when B+P (adjusted risk difference [97.5% CI]: -2% [-10% to 6%]) or PA (4% [-4% to 12%]) was compared with C+P. The mean (SD) number of episodes of dental pain and/or infection were as follows: C+P, 0.62 (0.95); B+P, 0.58 (0.87); and PA, 0.72 (0.98). Superiority could not be concluded for number of episodes between B+P (adjusted incident rate ratio (97.5% CI): 0.95 [0.75 to 1.21]) or PA (1.18 [0.94 to 1.48]) and C+P. In conclusion, there was no evidence of a difference among the 3 treatment approaches for incidence or number of episodes of dental pain and/or infection experienced by these participants with high caries risk and established disease (trial registration: ISRCTN77044005).

Background: This first mixed-methods UK trial examined the feasibility and acceptability of a future definitive randomised controlled trial (RCT) to evaluate whether Family Focussed Treatment for Adolescents with Bipolar Disorder (FFT-A) UK version can improve family functioning and well-being as part of the management of Paediatric Bipolar Disorder (PBD). Method: The trial used a randomised, parallel group, non-blinded design where participants received FFT-A UK (16 sessions over 6 months) immediately or after 12 months (delayed arm). Measures of family functioning, well-being and quality of life of the young person and the main carer (most commonly a parent) were completed at baseline, 6 and 12-months in both arms. Primary outcome measures included rates of eligibility, consent and retention along with estimates of variability in the measures and assessment of the intervention delivery. Qualitative interviews allowed assessment of participants' views about FFT-A and the trial processes. Results: Twenty-seven of 36 young persons with PBD and their families consented; of these, 14 families were randomised to the immediate and 13 to the delayed arm. Two families from the immediate arm withdrew consent and discontinued participation. Quantitative measures were completed by 22 families (88%) at 6-months and 21 families (84%) at 12-months. Qualitative interviews were conducted with 30 participants (9 young people, 15 parents and 6 other family members). Nine families attended 3 post-trial focus groups. Conclusion: It was feasible to recruit and retain to this trial. The results highlighted that trial design and measures were acceptable to participants. A benefit in family relationships was reported by participants which they attributed to the intervention in qualitative interviews. Families recommended that future modifications include definitive trial(s) recruiting participants in the age range 15-25 years as it felt this was the age range with maximum need.

OBJECTIVES:The FiCTION trial compared co-primary outcomes (dental pain and/or infection) and secondary outcomes (child oral health-related quality of life [COHRQOL], child dental anxiety, cost-effectiveness, caries development/progression and acceptability) across three treatment strategies (Conventional with Prevention [C + P]; Biological with Prevention [B + P]; Prevention Alone [PA]) for managing caries in children in primary care. COHRQOL and child dental anxiety experiences are reported upon here. METHODS:A multi-centre, 3-arm, parallel-group, unblinded patient-randomized controlled trial of 3- to 7-year-olds treated under NHS contracts was conducted in 72 general dental practices in England, Wales and Scotland. Child participants (with at least one primary molar with dentinal caries) were randomized (1:1:1) to one of three treatment arms with the intention of being managed according to allocated arm for 3 years (minimum 23 months). Randomization was via a centrally administered system using random permuted blocks of variable length. At baseline and final visit, accompanying parents/caregivers completed a parental questionnaire including COHRQOL (16 item P-CPQ-16), and at every visit, child- and parental-questionnaire-based data were collected for child-based dental trait and state anxiety. Statistical analyses were conducted on complete cases from the modified intention-to-treat (mITT) analysis set. RESULTS:A total of 1144 children were randomized (C + P: 386; B + P: 381; PA: 377). The mITT analysis set included the 1058 children who attended at least one study visit (C + P: 352; B + P: 352; PA: 354). Median follow-up was 33.8 months (IQR: 23.8, 36.7). The P-CPQ-16 overall score could be calculated after simple imputation at both baseline and final visit for 560 children (C + P: 189; B + P: 189; PA: 182). There was no evidence of a difference in the estimated adjusted mean P-CPQ-16 at the final visit which was, on average, 0.3 points higher (97.5% CI: -1.1 to 1.6) in B + P than C + P and 0.2 points higher, on average, (97.5% CI: -1.2 to 1.5) in PA than for C + P. Child dental trait anxiety and child dental state anxiety, measured at every treatment visit, showed no evidence of any statistically or clinically significant difference between arms in adjusted mean scores averaged over all follow-up visits. CONCLUSIONS:The differences noted in COHRQOL and child-based dental trait and dental state anxiety measures across three treatment strategies for managing dental caries in primary teeth were small, and not considered to be clinically meaningful. The findings highlight the importance of including all three strategies in a clinician's armamentarium, to manage childhood caries throughout the young child's life and achieve positive experiences of dental care.

BACKGROUND:Historically, lack of evidence for effective management of decay in primary teeth has caused uncertainty, but there is emerging evidence to support alternative strategies to conventional fillings, which are minimally invasive and prevention orientated. OBJECTIVES:The objectives were (1) to assess the clinical effectiveness and cost-effectiveness of three strategies for managing caries in primary teeth and (2) to assess quality of life, dental anxiety, the acceptability and experiences of children, parents and dental professionals, and caries development and/or progression. DESIGN:This was a multicentre, three-arm parallel-group, participant-randomised controlled trial. Allocation concealment was achieved by use of a centralised web-based randomisation facility hosted by Newcastle Clinical Trials Unit. SETTING:This trial was set in primary dental care in Scotland, England and Wales. PARTICIPANTS:Participants were NHS patients aged 3-7 years who were at a high risk of tooth decay and had at least one primary molar tooth with decay into dentine, but no pain/sepsis. INTERVENTIONS:Three interventions were employed: (1) conventional with best-practice prevention (local anaesthetic, carious tissue removal, filling placement), (2) biological with best-practice prevention (sealing-in decay, selective carious tissue removal and fissure sealants) and (3) best-practice prevention alone (dietary and toothbrushing advice, topical fluoride and fissure sealing of permanent teeth). MAIN OUTCOME MEASURES:The clinical effectiveness outcomes were the proportion of children with at least one episode (incidence) and the number of episodes, for each child, of dental pain or dental sepsis or both over the follow-up period. The cost-effectiveness outcomes were the cost per incidence of, and cost per episode of, dental pain and/or dental sepsis avoided over the follow-up period. RESULTS:A total of 72 dental practices were recruited and 1144 participants were randomised (conventional arm, n = 386; biological arm, n = 381; prevention alone arm, n = 377). Of these, 1058 were included in an intention-to-treat analysis (conventional arm, n = 352; biological arm, n = 352; prevention alone arm, n = 354). The median follow-up time was 33.8 months (interquartile range 23.8-36.7 months). The proportion of children with at least one episode of pain or sepsis or both was 42% (conventional arm), 40% (biological arm) and 45% (prevention alone arm). There was no evidence of a difference in incidence or episodes of pain/sepsis between arms. When comparing the biological arm with the conventional arm, the risk difference was -0.02 (97.5% confidence interval -0.10 to 0.06), which indicates, on average, a 2% reduced risk of dental pain and/or dental sepsis in the biological arm compared with the conventional arm. Comparing the prevention alone arm with the conventional arm, the risk difference was 0.04 (97.5% confidence interval -0.04 to 0.12), which indicates, on average, a 4% increased risk of dental pain and/or dental sepsis in the prevention alone arm compared with the conventional arm. Compared with the conventional arm, there was no evidence of a difference in episodes of pain/sepsis among children in the biological arm (incident rate ratio 0.95, 97.5% confidence interval 0.75 to 1.21, which indicates that there were slightly fewer episodes, on average, in the biological arm than the conventional arm) or in the prevention alone arm (incident rate ratio 1.18, 97.5% confidence interval 0.94 to 1.48, which indicates that there were slightly more episodes in the prevention alone arm than the conventional arm). Over the willingness-to-pay values considered, the probability of the biological treatment approach being considered cost-effective was approximately no higher than 60% to avoid an incidence of dental pain and/or dental sepsis and no higher than 70% to avoid an episode of pain/sepsis. CONCLUSIONS:There was no evidence of an overall difference between the three treatment approaches for experience of, or number of episodes of, dental pain or dental sepsis or both over the follow-up period. FUTURE WORK:Recommendations for future work include exploring barriers to the use of conventional techniques for carious lesion detection and diagnosis (e.g. radiographs) and developing and evaluating suitable techniques and strategies for use in young children in primary care. TRIAL REGISTRATION:Current Controlled Trials ISRCTN77044005. FUNDING:This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 1. See the NIHR Journals Library website for further project information.

Tobacco smoking is a major risk factor for several oral diseases, including periodontitis, and electronic cigarettes (e-cigarettes) are increasingly being used for smoking cessation. This study aimed to assess the viability of delivering and evaluating an e-cigarette intervention for smoking cessation within the dental setting, prior to a definitive study. A feasibility study, comprising a pilot randomised controlled trial and qualitative process evaluation, was conducted over 22 months in the Newcastle upon Tyne Hospitals NHS Dental Clinical Research Facility, UK. The pilot trial comprised a two-armed, parallel group, individually randomised, controlled trial, with 1:1 allocation. Participant eligibility criteria included being a tobacco smoker, having periodontitis and not currently using an e-cigarette. All participants received standard non-surgical periodontal therapies and brief smoking cessation advice. The intervention group additionally received an e-cigarette starter kit with brief training. Proposed outcomes for a future definitive trial, in terms of smoking behaviour and periodontal/oral health, were collected over 6 months to assess data yield and quality and estimates of parameters. Analyses were descriptive, with 95% confidence intervals presented, where appropriate. Eighty participants were successfully recruited from a range of dental settings. Participant retention was 73% (n = 58; 95% CI 62–81%) at 6 months. The e-cigarette intervention was well received, with usage rates of 90% (n = 36; 95% CI 77–96%) at quit date. Twenty percent (n = 8; 95% CI 11–35%) of participants in the control group used an e-cigarette at some point during the study (against advice). The majority of the outcome measures were successfully collected, apart from a weekly smoking questionnaire (only 30% of participants achieved ≥ 80% completion). Reductions in expired air carbon monoxide over 6 months of 6 ppm (95% CI 1–10 ppm) and 12 ppm (95% CI 8–16 ppm) were observed in the control and intervention groups, respectively. Rates of abstinence (carbon monoxide-verified continuous abstinence for 6 months) for the two groups were 5% (n = 2; 95% CI 1–17%; control group) and 15% (n = 6; 95% CI 7–29%; intervention group). Data suggest that a definitive trial is feasible and that the intervention may improve smoking quit rates. Insights were gained into how best to conduct the definitive trial and estimates of parameters to inform design were obtained. ISRCTN, ISRCTN17731903; registered 19 September 2016 http://www.isrctn.com/ISRCTN17731903 .

Background Cough is a common, disabling symptom of idiopathic pulmonary fibrosis (IPF), which may be exacerbated by acid reflux. Inhibiting gastric acid secretion could potentially reduce cough. This study aimed to determine the feasibility of a larger, multicentre trial of omeprazole for cough in IPF, to assess safety and to quantify cough. Methods Single-centre, double-blind, randomised, placebo-controlled pilot trial of the proton pump inhibitor (PPI) omeprazole (20 mg twice daily for 3 months) in patients with IPF. Primary objectives were to assess feasibility and acceptability of trial procedures. The primary clinical outcome was cough frequency. Results Forty-five participants were randomised (23 to omeprazole, 22 to placebo), with 40 (20 in each group) having cough monitoring before and after treatment. 280 patients were screened to yield these numbers, with barriers to discontinuing antacids the single biggest reason for non-recruitment. Recruitment averaged 1.5 participants per month. Geometric mean cough frequency at the end of treatment, adjusted for baseline, was 39.1% lower (95% CI 66.0% lower to 9.3% higher) in the omeprazole group compared with placebo. Omeprazole was well tolerated and adverse event profiles were similar in both groups, although there was a small excess of lower respiratory tract infection and a small fall in forced expiratory volume and forced vital capacity associated with omeprazole. Conclusions A large randomised controlled trial of PPIs for cough in IPF appears feasible and justified but should address barriers to randomisation and incorporate safety assessments in relation to respiratory infection and changes in lung function.

Introduction: Serum thyroid-stimulating hormone (TSH) increases with age but target TSH is similar in younger and older hypothyroid patients on treatment. It is unknown if quality of life (QoL), hypothyroid symptoms and cardiovascular risk factors change in older hypothyroid patients treated to an age-appropriate reference range. Objective: To assess if a higher target serum TSH of 4.01–8.0 mU/L is feasible in, and acceptable to, older treated hypothyroid patients. Methods: A single-blind (participant) randomised controlled feasibility trial involving 48 hypothyroid patients aged ≥80 years on established and stable levothyroxine (LT4) therapy with serum TSH levels within the standard reference range (0.4–4.0 mU/L) was conducted. Standard (0.4–4.0 mU/L) or higher (4.1–8.0 mU/L) TSH target (standard TSH [ST] or higher TSH [HT] groups) LT4 for 24 weeks was administered. The outcome measures evaluated were thyroid function tests, QoL, hypothyroid symptoms, cardiovascular risk factors and serum marker of bone resorption in participants that completed the trial (n = 21/24 ST group, n = 19/24 HT group). Results: At 24 weeks, in the ST and HT groups, respectively, median (interquartile range) serum TSH was 1.25 (0.76–1.72) and 5.50 (4.05–9.12) mU/L, mean (± SD) free thyroxine (FT4) was 19.4 ± 3.5 and 15.9 ± 2.4 pmol/L, and daily LT4 dose was 82.1 ± 26.4 and 59.2 ± 23.9 µg. There was no suggestion of adverse impact of a higher serum TSH in the HT group with regard to any of the outcomes assessed. Conclusions: In hypothyroid patients aged ≥80 years on LT4 therapy for 24 weeks, there was no evidence that a higher target serum TSH was associated with an adverse impact on patient reported outcomes, cardiovascular risk factors or bone resorption marker over 24 weeks. Longer-term trials assessing morbidity and mortality outcomes and health-utility in this age group are feasible and should be performed.

Journal of PeriodontologyVolume 89, Issue 5 p. 515-516 LETTER TO THE EDITOR Letter to the editor: RE: Comparison of periodontal parameters and self-perceived oral symptoms among cigarette smokers, individuals vaping electronic cigarettes and never-smokers: A pilot study Richard Holliday, Corresponding Author Richard Holliday richard.holliday@newcastle.ac.uk School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK Correspondence Richard Holliday, School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK. Email: richard.holliday@newcastle.ac.ukSearch for more papers by this authorVicky Ryan, Vicky Ryan Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UKSearch for more papers by this authorElaine McColl, Elaine McColl Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UKSearch for more papers by this authorPhilip M. Preshaw, Philip M. Preshaw School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UKSearch for more papers by this author Richard Holliday, Corresponding Author Richard Holliday richard.holliday@newcastle.ac.uk School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK Correspondence Richard Holliday, School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UK. Email: richard.holliday@newcastle.ac.ukSearch for more papers by this authorVicky Ryan, Vicky Ryan Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UKSearch for more papers by this authorElaine McColl, Elaine McColl Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UKSearch for more papers by this authorPhilip M. Preshaw, Philip M. Preshaw School of Dental Sciences, Newcastle University, Newcastle upon Tyne, UKSearch for more papers by this author First published: 24 April 2018 https://doi.org/10.1002/JPER.17-0591Citations: 1Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article.Citing Literature Volume89, Issue5May 2018Pages 515-516 RelatedInformation

Bronchiectasis presents a significant burden of disease for patients, their families and healthcare services, with recurrent hospital admissions and poorer health-related quality of life, in addition to higher rates of fatigue, depression and cardiovascular disease [1–3]. The increasing prevalence and burden of bronchiectasis is recognised worldwide [3–6]. Patient education is a fundamental part of long-term management planning, as highlighted in the new European Respiratory Society guidelines, yet there is a lack of information available to patients in comparison to other chronic respiratory conditions. Improvements in information for those living with bronchiectasis should use patient-driven co-development processes http://ow.ly/vWCB30iCn2M