Helen Victoria Worthington

Background Surgery is a common treatment option in oral cavity cancer (and less frequently in oropharyngeal cancer) to remove the primary tumour and sometimes neck lymph nodes. People with early‐stage disease may undergo surgery alone or surgery plus radiotherapy, chemotherapy, immunotherapy/biotherapy, or a combination of these. Timing and extent of surgery varies. This is the third update of a review originally published in 2007. Objectives To evaluate the relative benefits and harms of different surgical treatment modalities for oral cavity and oropharyngeal cancers. Search methods We used standard, extensive Cochrane search methods. The latest search date was 9 February 2022. Selection criteria Randomised controlled trials (RCTs) that compared two or more surgical treatment modalities, or surgery versus other treatment modalities, for primary tumours of the oral cavity or oropharynx. Data collection and analysis Our primary outcomes were overall survival, disease‐free survival, locoregional recurrence, and recurrence; and our secondary outcomes were adverse effects of treatment, quality of life, direct and indirect costs to patients and health services, and participant satisfaction. We used standard Cochrane methods. We reported survival data as hazard ratios (HRs). For overall survival, we reported the HR of mortality, and for disease‐free survival, we reported the combined HR of new disease, progression, and mortality; therefore, HRs below 1 indicated improvement in these outcomes. We used GRADE to assess certainty of evidence for each outcome. Main results We identified four new trials, bringing the total number of included trials to 15 (2820 participants randomised, 2583 participants analysed). For objective outcomes, we assessed four trials at high risk of bias, three at low risk, and eight at unclear risk. The trials evaluated nine comparisons; none compared different surgical approaches for excision of the primary tumour. Five trials evaluated elective neck dissection (ND) versus therapeutic (delayed) ND in people with oral cavity cancer and clinically negative neck nodes. Elective ND compared with therapeutic ND probably improves overall survival (HR 0.64, 95% confidence interval (CI) 0.50 to 0.83; I² = 0%; 4 trials, 883 participants; moderate certainty) and disease‐free survival (HR 0.56, 95% CI 0.45 to 0.70; I² = 12%; 5 trials, 954 participants; moderate certainty), and probably reduces locoregional recurrence (HR 0.58, 95% CI 0.43 to 0.78; I² = 0%; 4 trials, 458 participants; moderate certainty) and recurrence (RR 0.58, 95% CI 0.48 to 0.70; I² = 0%; 3 trials, 633 participants; moderate certainty). Elective ND is probably associated with more adverse events (risk ratio (RR) 1.31, 95% CI 1.11 to 1.54; I² = 0%; 2 trials, 746 participants; moderate certainty). Two trials evaluated elective radical ND versus elective selective ND in people with oral cavity cancer, but we were unable to pool the data as the trials used different surgical procedures. Neither study found evidence of a difference in overall survival (pooled measure not estimable; very low certainty). We are unsure if there is a difference in effect on disease‐free survival (HR 0.57, 95% CI 0.29 to 1.11; 1 trial, 104 participants; very low certainty) or recurrence (RR 1.21, 95% CI 0.63 to 2.33; 1 trial, 143 participants; very low certainty). There may be no difference between the interventions in terms of adverse events (1 trial, 148 participants; low certainty). Two trials evaluated superselective ND versus selective ND, but we were unable to use the data. One trial evaluated supraomohyoid ND versus modified radical ND in 332 participants. We were unable to use any of the primary outcome data. The evidence on adverse events was very uncertain, with more complications, pain, and poorer shoulder function in the modified radical ND group. One trial evaluated sentinel node biopsy versus elective ND in 279 participants. There may be little or no difference between the interventions in overall survival (HR 1.00, 95% CI 0.90 to 1.11; low certainty), disease‐free survival (HR 0.98, 95% CI 0.90 to 1.07; low certainty), or locoregional recurrence (HR 1.04, 95% CI 0.91 to 1.19; low certainty). The trial provided no usable data for recurrence, and reported no adverse events (very low certainty). One trial evaluated positron emission tomography‐computed tomography (PET‐CT) following chemoradiotherapy (with ND only if no or incomplete response) versus planned ND (before or after chemoradiotherapy) in 564 participants. There is probably no difference between the interventions in overall survival (HR 0.92, 95% CI 0.65 to 1.31; moderate certainty) or locoregional recurrence (HR 1.00, 95% CI 0.94 to 1.06; moderate certainty). One trial evaluated surgery plus radiotherapy versus radiotherapy alone and provided very low‐certainty evidence of better overall survival in the surgery plus radiotherapy group (HR 0.24, 95% CI 0.10 to 0.59; 35 participants). The data were unreliable because the trial stopped early and had multiple protocol violations. In terms of adverse events, subcutaneous fibrosis was more frequent in the surgery plus radiotherapy group, but there were no differences in other adverse events (very low certainty). One trial evaluated surgery versus radiotherapy alone for oropharyngeal cancer in 68 participants. There may be little or no difference between the interventions for overall survival (HR 0.83, 95% CI 0.09 to 7.46; low certainty) or disease‐free survival (HR 1.07, 95% CI 0.27 to 4.22; low certainty). For adverse events, there were too many outcomes to draw reliable conclusions. One trial evaluated surgery plus adjuvant radiotherapy versus chemotherapy. We were unable to use the data for any of the outcomes reported (very low certainty). Authors' conclusions We found moderate‐certainty evidence based on five trials that elective neck dissection of clinically negative neck nodes at the time of removal of the primary oral cavity tumour is superior to therapeutic neck dissection, with increased survival and disease‐free survival, and reduced locoregional recurrence. There was moderate‐certainty evidence from one trial of no difference between positron emission tomography (PET‐CT) following chemoradiotherapy versus planned neck dissection in terms of overall survival or locoregional recurrence. The evidence for each of the other seven comparisons came from only one or two studies and was assessed as low or very low‐certainty.

Background: Traditionally, patients are encouraged to attend dental recall appointments at regular 6-month intervals, irrespective of their risk of developing dental disease. Stakeholders lack evidence of the relative effectiveness and cost-effectiveness of different recall strategies and the optimal recall interval for maintenance of oral health.Objectives: To test effectiveness and assess the cost–benefit of different dental recall intervals over a 4-year period.Design: Multicentre, parallel-group, randomised controlled trial with blinded clinical outcome assessment at 4 years and a within-trial cost–benefit analysis. NHS and participant perspective costs were combined with benefits estimated from a general population discrete choice experiment. A two-stratum trial design was used, with participants randomised to the 24-month interval if the recruiting dentist considered them clinically suitable. Participants ineligible for 24-month recall were randomised to a risk-based or 6-month recall interval.Setting: UK primary care dental practices.Participants: Adult, dentate, NHS patients who had visited their dentist in the previous 2 years.Interventions: Participants were randomised to attend for a dental check-up at one of three dental recall intervals: 6-month, risk-based or 24-month recall.Main outcomes: Clinical – gingival bleeding on probing; patient – oral health-related quality of life; economic – three analysis frameworks: (1) incremental cost per quality-adjusted life-year gained, (2) incremental net (societal) benefit and (3) incremental net (dental health) benefit.Results: A total of 2372 participants were recruited from 51 dental practices; 648 participants were eligible for the 24-month recall stratum and 1724 participants were ineligible. There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding between intervention arms in any comparison. For the eligible for 24-month recall stratum: the 24-month (n = 138) versus 6-month group (n = 135) had an adjusted mean difference of –0.91 (95% confidence interval –5.02 to 3.20); the risk-based (n = 143) versus 6-month group had an adjusted mean difference of –0.98 (95% confidence interval –5.05 to 3.09); the 24-month versus risk-based group had an adjusted mean difference of 0.07 (95% confidence interval –3.99 to 4.12). For the overall sample, the risk-based (n = 749) versus 6-month (n = 737) adjusted mean difference was 0.78 (95% confidence interval –1.17 to 2.72). There was no evidence of a difference in oral health-related quality of life between intervention arms in any comparison. For the economic evaluation, under framework 1 (cost per quality-adjusted life-year) the results were highly uncertain, and it was not possible to identify the optimal recall strategy. Under framework 2 (net societal benefit), 6-month recalls were the most efficient strategy with a probability of positive net benefit ranging from 78% to 100% across the eligible and combined strata, with findings driven by the high value placed on more frequent recall services in the discrete choice experiment. Under framework 3 (net dental health benefit), 24-month recalls were the most likely strategy to deliver positive net (dental health) benefit among those eligible for 24-month recall, with a probability of positive net benefit ranging from 65% to 99%. For the combined group, the optimal strategy was less clear. Risk-based recalls were more likely to be the most efficient recall strategy in scenarios where the costing perspective was widened to include participant-incurred costs, and in the Scottish subgroup.Limitations: Information regarding factors considered by dentists to inform the risk-based interval and the interaction with patients to determine risk and agree the interval were not collected.Conclusions: Over a 4-year period, we found no evidence of a difference in oral health for participants allocated to a 6-month or a risk-based recall interval, nor between a 24-month, 6-month or risk-based recall interval for participants eligible for a 24-month recall. However, people greatly value and are willing to pay for frequent dental check-ups; therefore, the most efficient recall strategy depends on the scope of the cost and benefit valuation that decision-makers wish to consider.Future work: Assessment of the impact of risk assessment tools in informing risk-based interval decision-making and techniques for communicating a variable recall interval to patients.Trial registration: Current Controlled Trials ISRCTN95933794.Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme [project numbers 06/35/05 (Phase I) and 06/35/99 (Phase II)] and will be published in full inHealth Technology Assessment; Vol. 24, No. 60. See the NIHR Journals Library website for further project information.

Objectives To evaluate the clinical-effectiveness of oral splints for patients with TMD or bruxism for the primary outcomes: pain (TMD) and tooth wear (bruxism).Data sources Four databases including MEDLINE and EMBASE were searched from inception until 1 October 2018.Data selection and extraction Randomised controlled trials comparing all types of splints versus no/minimal treatment for patients with TMD or bruxism were eligible. Standard Cochrane review methods were used. Standardised mean differences (SMD) were pooled for the primary outcome of pain, using random effects models in TMD patients.Data synthesis Thirty-seven trials were included and the evidence identified was of very low certainty using GRADE assessments. When all subtypes of TMD were pooled into one global TMD group, there was no evidence that splints reduced pain: SMD (up to 3 months) -0.18 (95% CI -0.42 to 0.06); 13 trials, 1,076 participants. There was no evidence that any other outcomes improved when using splints. There was no evidence of adverse events associated with splints, but reporting was poor regarding this outcome. No trials measured tooth wear in patients with bruxism. There was a large variation in diagnostic criteria, splint types and outcome measures used and reported. Sensitivity analyses based on these factors did not indicate a reduction in pain.Conclusions The very low-certainty evidence identified did not demonstrate that splints reduced pain in TMD as a group of conditions. There is insufficient evidence to determine whether splints reduce tooth wear in patients with bruxism.

Background: Splints are a non-invasive, reversible management option for temporomandibular disorders or bruxism. The clinical effectiveness and cost-effectiveness of splints remain uncertain.Objectives: The objectives were to evaluate the clinical effectiveness and cost-effectiveness of splints for patients with temporomandibular disorders or bruxism. This evidence synthesis compared (1) all types of splint versus no/minimal treatment/control splints and (2) prefabricated versus custom-made splints, for the primary outcomes, which were pain (temporomandibular disorders) and tooth wear (bruxism).Review methods: Four databases, including MEDLINE and EMBASE, were searched from inception until 1 October 2018 for randomised clinical trials. The searches were conducted on 1 October 2018. Cochrane review methods (including risk of bias) were used for the systematic review. Standardised mean differences were pooled for the primary outcome of pain, using random-effects models in temporomandibular disorder patients. A Markov cohort, state-transition model, populated using current pain and Characteristic Pain Intensity data, was used to estimate the incremental cost-effectiveness ratio for splints compared with no splint, from an NHS perspective over a lifetime horizon. A value-of-information analysis identified future research priorities.Results: Fifty-two trials were included in the systematic review. The evidence identified was of very low quality with unclear reporting by temporomandibular disorder subtype. When all subtypes were pooled into one global temporomandibular disorder group, there was no evidence that splints reduced pain [standardised mean difference (at up to 3 months) –0.18, 95% confidence interval –0.42 to 0.06; substantial heterogeneity] when compared with no splints or a minimal intervention. There was no evidence that other outcomes, including temporomandibular joint noises, decreased mouth-opening, and quality of life, improved when using splints. Adverse events were generally not reported, but seemed infrequent when reported. The most plausible base-case incremental cost-effectiveness ratio was uncertain and driven by the lack of clinical effectiveness evidence. The cost-effectiveness acceptability curve showed splints becoming more cost-effective at a willingness-to-pay threshold of ≈£6000, but the probability never exceeded 60% at higher levels of willingness to pay. Results were sensitive to longer-term extrapolation assumptions. A value-of-information analysis indicated that further research is required. There were no studies measuring tooth wear in patients with bruxism. One small study looked at pain and found a reduction in the splint group [mean difference (0–10 scale) –2.01, 95% CI –1.40 to –2.62; very low-quality evidence]. As there was no evidence of a difference between splints and no splints, the second objective became irrelevant.Limitations: There was a large variation in the diagnostic criteria, splint types and outcome measures used and reported. Sensitivity analyses based on these limitations did not indicate a reduction in pain.Conclusions: The very low-quality evidence identified did not demonstrate that splints reduced pain in temporomandibular disorders as a group of conditions. There is insufficient evidence to determine whether or not splints reduce tooth wear in patients with bruxism. There remains substantial uncertainty surrounding the most plausible incremental cost-effectiveness ratio.Future work: There is a need for well-conducted trials to determine the clinical effectiveness and cost-effectiveness of splints in patients with carefully diagnosed and subtyped temporomandibular disorders, and patients with bruxism, using agreed measures of pain and tooth wear.Study registration: This study is registered as PROSPERO CRD42017068512.Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 24, No. 7. See the NIHR Journals Library website for further project information.

Cochrane Oral Health withdrew this review as of Issue 10, 2019 at Cochrane's Funding Arbiters' request. The review is out‐of‐date but it is correct at the date of publication. The review has been withdrawn from the Cochrane Library, but readers can still access previous versions by selecting 'View version history.'

Introduction Obstructive sleep apnoea-hypopnea syndrome (OSAHS) is characterised by recurring episodes of complete or partial upper airway collapse during sleep. Persistent OSAHS is associated with long-term consequences, such as growth failure, cardiovascular and neurocognitive problems in children. Different from the aetiology of OSAHS in adults, the most common cause of paediatric OSAHS is adenotonsillar hypertrophy. Adenotonsillectomy (AT) has been recommended as the first-line treatment of paediatric OSAHS. Several studies have suggested that retarded growth caused by OSAHS can improve after AT during the prepubertal period. This review will systematically search and summarise the available evidence on the effects of AT on children’s growth. Methods and analysis We will conduct electronic searches in MEDLINE (via PubMed), Embase, Google Scholar and the Cochrane Central Register of Controlled Trials for randomised controlled trials (RCTs) or cohort studies that included a control group. Additional records will be searched by checking the references included in the selected studies and relevant reviews. At least two authors will undertake selection of studies and data extraction independently and in duplicate. The Cochrane Risk of Bias tool and Risk Of Bias In Non-randomised Studies—of Interventions will be used to assess the risk of bias of RCT and cohort studies, respectively. A random-effects model will be used for meta-analyses. Data synthesis and other analyses will be carried out using the RevMan V.5.3 software. The Grades of Recommendation, Assessment, Development and Evaluation will be used to assess the quality of the supporting evidence behind each main comparison. Ethics and dissemination There is no ethical issue in this systematic review given that we will only include published studies. The results will be disseminated via peer-reviewed publications and social networks. PROSPERO registration number CRD42019125882