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Biomedical subjects

N Steen

Publications and source records attributed to N Steen.

At least 19 recordsLinked to original sources

Cerebral autoregulation is impaired in cardioinhibitory carotid sinus syndrome.

OBJECTIVES: To compare changes in cerebral autoregulation in response to controlled, lower body negative pressure-induced hypotension in patients with carotid sinus syndrome (CSS) and case controls. DESIGN: Prospective case controlled study. SETTING: Secondary and tertiary referral falls and syncope service. PATIENTS: 17 consecutive patients with CSS and 11 asymptomatic controls. INTERVENTIONS: Hypotension insufficient to cause syncope induced by lower body negative pressure (minimum 30 mm Hg fall in systolic blood pressure (SBP)) during concomitant transcranial Doppler ultrasonography. MAIN OUTCOME MEASURES: Cerebral autoregulation (systolic, diastolic and mean middle cerebral arterial blood flow velocities and cerebrovascular resistance) with continuous end-tidal carbon dioxide and haemodynamic monitoring. RESULTS: Cerebral autoregulatory indices differed significantly between patients with CSS and controls. Systolic, diastolic and middle cerebral arterial blood flow velocities were, respectively, 9.2 m/s (95% confidence interval (CI) 2.9 to 15.4 m/s), 4.7 m/s (95% CI 1.5 to 7.9 m/s) and 6.9 m/s (95% CI 2.5 to 11.4 m/s) slower in patients with CSS. Cerebrovascular resistance was significantly greater in patients with CSS than in controls at SBP nadir and suction release; differences were 0.9 mm Hg/m/s (95% CI 0.0 to 1.7 mm Hg/m/s) and 0.8 mm Hg/m/s (95% CI 0.0 to 1.7 mm Hg/m/s), respectively. End-tidal carbon dioxide and systemic haemodynamic variables were similar for patients and controls at baseline and during lower body negative pressure. CONCLUSIONS: Cerebral autoregulation is altered in patients with CSS. This difference may have aetiological implications in the differential presentation with falls and drop attacks rather than syncope.

Aged↗

The equity of access to primary dental care for children in the North East of England.

OBJECTIVES: To determine the equity of access to dental care from general dental practitioners for children aged 0 to 17 years. BASIC RESEARCH DESIGN: Postcode data was obtained from the Dental Practice Board for children registered with an NHS dentist. There were 146,180 children aged 0 to 17 years old resident in the study area, these were mapped to their ward of residence. The child registration rate for wards was calculated, using 2001 census data. The level of deprivation for wards was obtained using a standard indicator, the Index of Multiple Deprivation. SETTING: The Durham and Tees Valley Strategic Health Authority area in the North East of England. The Authority has a population of 1.13 million, of which 260,000 were aged 0 to 17, in 2001. There are approximately 170 dental practices in the Authority area contained in 251 Wards. RESULTS: The range of child registration rates in wards was, 11% to 90%. There was a significant negative association between the number of children registered with a dental practice and increasing deprivation. For every 10 point increase in the deprivation score the probability of registration reduced by 5% of the overall rate. The probability of registration reduced less in those wards with a dental practice compared to those without a dental practice with increasing deprivation. CONCLUSIONS: There are significant inequalities in access to dental care. Children living in deprived wards access general dental practices less than those living in wealthier wards. The location of dental practices may reduce inequalities in access.

Adolescent↗

Assessing adherence with toothbrushing instructions using a data logger toothbrush.

OBJECTIVES: To evaluate patient compliance with toothbrushing instructions using a data logger and a brushing diary. METHODS: Dental patients were provided with powered toothbrushes modified to carry electronic data loggers. Demonstration of the most effective way to use the toothbrush was provided with instructions to brush for 2 minutes morning and evening. Data logger brushes were supplied for two episodes of 8 weeks. Brushing time was also recorded in a diary during episode 1. RESULTS: Data from 14 brushes (2,287 recordings) were used to evaluate compliance in episode 1 Nine brushes (1,526 recordings) were used in episode 2 A total of 2,333 brushing events were reported manually in the diaries. Data logger records during episode 1 showed that only 34% of events were compliant with the instruction of a 2 minute brushing time, 20% were partially compliant (within +/-30s of 2 minutes), and 46% of events were non-compliant (>30s from 2 minutes). The respective proportions for episode 2 were 24%, 24% and 52%. Diary data reported 58% of events as compliant with 42% non-compliant. CONCLUSIONS: Manually completed brushing diaries do not provide an accurate reflection of subjects' compliance with toothbrushing instructions.

Data Collection↗

The effect of quitting smoking on chronic periodontitis.

OBJECTIVES: To evaluate longitudinally the effect of smoking cessation on clinical and radiographic outcomes following non-surgical treatment in smokers with chronic periodontitis. MATERIAL AND METHODS: Forty-nine smokers with chronic periodontitis who wished to quit smoking were recruited. Full-mouth probing depths, bleeding and plaque data were recorded at baseline, 3, 6 and 12 months. Clinical attachment levels were recorded at target sites and subtraction radiography was used to assess bone density changes. Patients received non-surgical periodontal therapy during the first 3 months and supportive periodontal care over the remainder of the study. Smoking cessation counselling was provided according to individual need. RESULTS: After 12 months, of patients with complete data, 10 had continuously quit smoking (20% of the original population), 10 continued smoking and six were oscillators (those patients who quit and then relapsed). There were no differences between the groups following treatment with respect to mean clinical or radiographic parameters. Analysis of probing depth reductions between baseline and month 12, however, and comparing quitters with the other two groups combined, demonstrated a significant difference in favour of quitters (p<0.05). Furthermore, quitters were significantly more likely to demonstrate probing depth reductions > or =2 and > or =3 mm than non-quitters and oscillators (p<0.05). CONCLUSION: Quitting smoking has an additional beneficial effect in reducing probing depths following non-surgical treatment over a 12-month period.

Adult↗

The crossover design to evaluate the efficacy of plaque removal in tooth-brushing studies.

OBJECTIVES: To evaluate the crossover clinical trial design to assess plaque removal efficacy of the Sonicare Elite. MATERIAL AND METHODS: A single-cohort, 12-week, two-treatment, single-blind, crossover clinical trial recruited 45 subjects. Plaque was recorded using the modified Quigley and Hein index plaque index (PI). After screening, subjects used the toothbrush for 2 weeks and were reminded to abstain from tooth cleaning 12-18 h prior to appointments. At visit two, subjects were randomized to 2 or 2(1/2) min. brushing time. PIs was recorded pre- and post-brushing. Subjects brushed for the allocated time for a further 2 weeks. At visit 3, PIs were recorded pre- and post-brushing. Two weeks later, at visit 4, the subjects crossed over and the protocol was repeated. RESULTS: There was no evidence of a learning effect within each arm of the crossover. A significant period effect was detected; however, no significant treatment by period effect was found. 2(1/2) min. brushing removed more plaque at full mouth (p=0.037), smooth (p=0.012) and lingual (p=0.002) sites compared with 2 min. CONCLUSION: The crossover design is a valid model for assessing plaque removal efficacy in tooth-brushing studies where no carry-over effect is clinically plausible.

Adolescent↗

A pragmatic randomised controlled trial of the cost-effectiveness of palliative therapies for patients with inoperable oesophageal cancer.

OBJECTIVES: To compare whether treatment with self-expanding metal stents (SEMS) is more cost-effective than treatment with conventional modalities in patients with inoperable oesophageal cancer. Quality of life effects were also considered. DESIGN: A multicentre pragmatic, randomised controlled trial with health economic analysis. SETTING: Seven NHS hospitals selected to represent a cross-section of UK hospitals in terms of facilities and staffing. PARTICIPANTS: All patients attending the centres with oesophageal cancer deemed unsuitable for surgery were assessed for inclusion in the main trial; 217 patients were randomised. A health state utilities substudy was also performed in 71 patients who had previously received curative surgery for oesophageal cancer. INTERVENTIONS: Eligible patients were randomised to one of four treatment groups within two study arms. Assessments were performed at enrolment, 1 week following treatment and thereafter at 6-weekly intervals until death, with prospective data collection on complications and survival. Structured interviews to elicit patient preferences to health states and treatments were performed in a substudy. MAIN OUTCOME MEASURES: Dysphagia grade and quality of life were examined at 6 weeks. Survival, resources consumed from randomisation to death and quality-adjusted life-years were also considered. RESULTS: There was no difference in cost or effectiveness between SEMS and non-SEMS therapies, and 18-mm SEMS had equal effectiveness to, but less associated pain than, 24-mm SEMS. Rigid intubation was associated with a worse quality of swallowing and increased late morbidity. Bipolar electrocoagulation and ethanol tumour necrosis were poor in primary palliation. A survival advantage was found for non-stent therapies, but there was a significant delay to treatment. The length of stay accounts for the majority of the cost to the NHS. Patients were found to have distinct individual treatment preferences. CONCLUSIONS: It was suggested that rigid tubes and 24-mm SEMS should no longer be recommended and bipolar electrocoagulation and ethanol tumour necrosis should not be used for primary palliation. The choice in palliation would between non-stent and 18-mm SEMS treatments, with non-stent therapies being made more available and accessible to reduce delay. A multidisciplinary team approach to palliation is also suggested. A randomised controlled clinical trial of 18-mm SEMS versus non-stent therapies with survival and quality of life end-points would be helpful, as would an audit of palliative patient admissions to determine the reasons and need for inpatient hospital care, with a view to implementing cycle-associated change to reduce inpatient stay. A study of delays in palliative radiotherapy treatment is also suggested, with a view to implementing cycle-associated change to reduce waiting time.

Aged↗

An RCT pilot study to test the effects of intravenous midazolam as a conscious sedation technique for anxious children requiring dental treatment--an alternative to general anaesthesia.

AIM: To add to the evidence base for acceptable and effective paediatric conscious sedation techniques in dental primary care. OBJECTIVES: To compare three conscious sedation techniques for primary care as an alternative to dental general anaesthesia (DGA) in children. To assess the feasibility and practicality of running the trial in general dental practice. To form the basis for sample size calculations and assess scales of measurement. DESIGN: Single centre, randomised control trial (RCT). SETTING: Queensway Anxiety Management Clinic (QAMC). A primary care based general and referral dental practice for the management of anxious patients. SUBJECTS, MATERIALS AND METHODS: Sixty five children too anxious for management with relative analgesia, requiring invasive dental procedure for which dental general anaesthesia (DGA) will be required if an alternative cannot be found. INTERVENTIONS: Group 1 (n = 20) - A combination of inhaled medical air and titrated intravenous midazolam. Group 2 (n = 22) - A combination of inhaled 40% nitrous oxide in oxygen and titrated intravenous midazolam. Group 3 (n = 23) - A combination of an inhaled mixture of 0.3% sevoflurane and 40% nitrous oxide in oxygen with titrated intravenous midazolam. MAIN OUTCOME MEASURES: Successful completion of the intended dental treatment with a child who is co-operative and responsive to verbal commands. RESULTS: Fifty per cent (ten children) successfully completed treatment in Group 1, 73% (16 children) in Group 2 and 83% (19 children) in Group 3. This difference was not significant at a 5% level (chi(2) = 5.53, df = 2, P = 0.07) Of the total of 20 failures, eight children in Group 1 and one child in Group 2 were successfully treated with the addition of sevoflurane and nitrous oxide in oxygen. Only two children required referral to a hospital setting for DGA and the remaining nine children were managed with an alternative conscious sedation technique. CONCLUSION: This pilot shows that intravenous midazolam especially in combination with the addition of inhaled nitrous oxide or sevoflurane and nitrous oxide were promising safe and effective techniques, sufficient to justify progression to a definitive RCT with appropriate methods.

Adolescent↗

A randomised controlled trial of paediatric conscious sedation for dental treatment using intravenous midazolam combined with inhaled nitrous oxide or nitrous oxide/sevoflurane.

Failure of dental treatment due to anxiety is a common problem in children. The aim of this study was to establish whether the use of a combination of intravenous midazolam with inhalation agents (nitrous oxide alone or in combination with sevoflurane) was any more likely to result in successful completion of treatment than midazolam alone. A further aim was to evaluate the clinical viability of these techniques as an alternative to general anaesthesia. In total, 697 children too anxious for management with relative analgesia and requiring invasive dental procedure for which a general anaesthetic would usually be required, were recruited and randomly assigned to one of three groups given the following interventions: group 1 - a combination of inhaled medical air and titrated intravenous midazolam, group 2 - a combination of inhaled 40% nitrous oxide in oxygen and titrated intravenous midazolam, and group 3 - a combination of an inhaled mixture of sevoflurane 0.3% and nitrous oxide 40% in oxygen with titrated intravenous midazolam. The primary outcome measure was successful completion of the intended dental treatment with a co-operative child responsive to verbal commands. In group 1, 54% (94/174 children) successfully completed treatment. In group 2, 80% (204/256 children) and in group 3, 93% (249/267 children) completed treatment. This difference was significant at the 1% level. Intravenous midazolam, especially in combination with inhaled nitrous oxide or sevoflurane and nitrous oxide, are effective techniques, with the combination of midazolam and sevoflurane the one most likely to result in successful treatment.

Adolescent↗

A clinical comparison of an oscillating/rotating powered toothbrush and a manual toothbrush in patients with chronic periodontitis.

OBJECTIVES PRIMARY OBJECTIVE: To compare the relative efficacy of an oscillating/rotating powered toothbrush to that of a conventional manual toothbrush in a group of periodontal patients over a 16-month period with respect to plaque control. SECONDARY OBJECTIVE: To compare differences in pocket depth (PD) and bleeding index (BI) between the two groups over a 16-month period. MATERIAL AND METHODS: Forty patients were recruited to a 16-month, single-blind, two-group, randomised, parallel group clinical trial to compare the effects of manual and oscillating/rotating powered toothbrushes in a cohort of patients with chronic periodontitis. None of the patients had previous experience of using an oscillating/rotating brush and had a mean plaque index (PI) of > 2.0 (modified Quigley and Hein index) at baseline. Patients were stratified by gender, age and smoking status then randomised to using a manual or an oscillating/rotating brush for the duration of the study. Conventional non-surgical periodontal therapy was undertaken within the first month after baseline. PI was the primary outcome measure with PDs and BI also recorded at baseline and months 3, 6, 10 and 16. RESULTS: Mean full-mouth (FM) scores at baseline for oscillating/rotating brushing and manual brushing groups were as follows: PI, 3.4 and 3.5; BI, 1.7 and 1.5; and PD, 3.4 and 3.3. The mean reduction in FM scores from baseline to 16 months were: PI, 0.72 and 0.75; PD, 0.43 and 0.57; and BI, 0.74 and 0.83, respectively. Repeated measures ANOVA were used to compare differences between groups (adjusted for baseline levels) at months 3, 6, 10 and 16 and showed no statistically significant difference between groups for PI and PD (p > 0.05). A difference of 0.2 BI units was detected in favour of the manual brushing group (p = 0.04). CONCLUSION: Over a 16-month period, there were no differences in PI reduction or PD reduction between patients who underwent non-surgical management of chronic periodontal disease and used either an oscillating/rotating powered toothbrush or a conventional manual toothbrush. A difference in gingival bleeding reduction was detected in favour of the patients allocated the manual brush.

Adult↗

Efficacy of plaque removal of the Sonicare Elite versus the Sonicare Advance from hard-to-reach sites.

OBJECTIVE: To compare the Sonicare Elite with the Sonicare Advance in terms of the reduction in supragingival plaque in the posterior, hard-to-reach areas of the mouth. METHOD: This was a single-cohort, 6-week, two-treatment, single-blind, cross-over clinical trial that recruited 45 subjects. Plaque scores were recorded throughout the study using a modification of the Quigley and Hein plaque index (PI). All subjects had a minimum pre-brushing PI of 1.8 at screening following 24 h abstention from tooth cleaning. Subjects then used a Sonicare Advance powered toothbrush at home for 4 weeks for familiarisation purposes. At the next visit (2), subjects were given either the Sonicare Elite or the Sonicare Advance powered toothbrush for a further 2 weeks of home use. Twenty-four hours prior to visit 3, subjects abstained again from tooth cleaning. At visit 3, the PI was recorded pre- and post-tooth brushing and then all remaining "mature" plaque was removed professionally with a dental prophylaxis. After a further period of 24 h (to accumulate new plaque) without tooth brushing the subjects returned for visit 4 at which PIs were again recorded pre- and post-tooth brushing. The subjects were then given the second toothbrush in the cross-over sequence and attended for visits 5 and 6 at which the protocol for visits 3 and 4 was repeated. RESULTS: The Sonicare Elite powered toothbrush was more effective than the Sonicare Advance model in removing both mature and newly formed plaque. The magnitude of the differences between the toothbrushes for all posterior sites, interproximal and smooth surfaces, respectively, was 0.35 U (p<0.001), 0.39 U (p<0.001) and 0.32 U (p<0.001) of the modified Quigley and Hein PI. There was no evidence of a significant period effect comparing data from visits 5 and 6 against those from visits 3 and 4. There was, however, a significant visit effect with full-mouth (p<0.01), interproximal (p<0.001) and smooth surface (p<0.01) post-brushing plaque scores being significantly lower at visits 4 and 6 than at visits 3 and 5. CONCLUSION: The data support the observation that the Sonicare Elite toothbrush is more effective than the Sonicare Advance model in removing both newly formed and mature plaque from all posterior, interproximal and smooth tooth surfaces.

Adolescent↗

The reliability of three perceptual evaluation scales for dysphonia.

Perceptual rating scales are widely used in voice quality assessment, yet apart from the GRBAS scale, their reliability has been poorly demonstrated. There are no studies that have compared the optimal reliability of experienced judges using different auditory rating scales in a controlled experimental environment. This study aimed to assess the reliability of three common scales (The Buffalo Voice Profile, The Vocal Profile Analysis Scheme (VPA) and GRBAS. Sixty-five varyingly dysphonic and five normal voices were recorded onto CD in random order. Thirty voices were recorded twice. Seven experienced and trained speech and language therapists rated all voices on the three scales. Only the overall grade was found to be reliable for the Buffalo Voice Profile. The reliability of the VPA scheme was found to be poor to moderate. The VPA may have a use as a multi-dimensional and in-depth evaluation of voice types, but its greater scope is at the expense of reliability. The GRBAS was reliable across all parameters except Strain. Our detailed reliability analysis comparing performance of three commonly used rating scales provides further evidence to support the GRBAS as a simple reliable measure for clinical use.

Adolescent↗

Assessing the long-term effect of educational reminder messages on primary care radiology referrals.

AIM: To investigate whether the effect of educational reminder messages for knee and lumbar spine radiographs varied over a 12 month period. MATERIALS AND METHODS: In a previous randomized, controlled trial, educational reminder messages attached to x-ray reports were shown to be effective in reducing the number of radiograph requests by general practitioners for knee and lumbar spine radiographs. In this study, all radiology departments from the previous trial were asked for monthly referral records for the 12 month intervention period for knee and lumbar spine radiographs for each general practice. Poisson regression was used to test for a change over time in the number of referrals between control and intervention practices. RESULTS: Data were obtained for 66% of the general practices in the main trial. The number of referrals for both knee and lumbar spine radiographs remained consistently and statistically significantly lower in the educational reminder messages group compared with the control group (relative risk=0.65 and 0.64, respectively). There was no evidence that this difference increased or decreased throughout the 12 month period. CONCLUSIONS: The effect of educational reminder messages was produced as soon as the intervention was delivered and maintained throughout the intervention period. There was no evidence of the effect of the intervention wearing off.

Family Practice↗

Effect of brushing force and time on plaque removal using a powered toothbrush.

OBJECTIVES: Primary objective - To determine the effect of varying brushing forces and brushing times upon the plaque-removing efficacy of a powered toothbrush. Secondary objective - to determine the optimum combination of brushing force and time for plaque removal. MATERIAL AND METHODS: This randomised, single-blind, 16-cell, cross-over trial compared the efficacy of plaque removal of a powered toothbrush (PTB) used with four brushing forces (75, 150, 225 and 300 g) and over four brushing times (30, 60, 120 and 180 s). Twelve volunteers (18-30 years) were recruited and trained to use the Philips/Jordan Sensiflex 2000 PTB, which was modified so that specified forces and times could be recorded. Each subject was asked to abstain from all oral hygiene procedures for 24 hs prior to each brushing event, to allow plaque accumulation. Plaque was recorded using a modified Quigley & Hein index (PI) at six points per tooth before and after each episode of brushing, and the differences in the means (pre- to postbrushing) were compared. Three-way anova was undertaken to compare differences between plaque-removing efficacy for the 16 combinations of force and time. Subjects, brushing time and brushing force were used as fixed effects within the analysis. RESULTS: All 12 subjects participating completed the 16 combinations of force and time over which plaque removal was assessed. Statistically significant differences in PI reductions were found between different brushing times and forces over all tooth surfaces (p<0.001). The interaction of varying brushing force and brushing time was significant for full mouth (FM) and interproximal (IP) sites (p<0.03). No statistical significance was demonstrated for smooth surface (SS) sites, nor was it detected for the interaction of subjects with brushing force or subjects with brushing time (p>0.05). CONCLUSION: We conclude that brushing time and brushing force have significant effects upon the level of plaque removal by a PTB, and at 120 s brushing time the improvement in plaque removal with forces in excess of 150 g was negligible.

Adult↗

Testing the efficacy of 2 prototype brush heads for a powered toothbrush: refining the model.

OBJECTIVES: To compare 2 prototype powered toothbrush (PTB) heads (A, B) to a marketed head (Sensiflex 2000) for plaque removing efficacy on the Philips/Jordan HX2550 PTB. MATERIALS AND METHODS: A 2-week, 3-group, single-blind trial recruited 78 volunteers (18-25). Plaque indices (PIs) were recorded at screening and 14 days later at baseline. Subjects were stratified (gender and PI) and then asked to abstain from oral hygiene measures for 48 h. A supervised episode of brushing with the allocated PTB head followed. Subjects then used the PTBs at home for the next 12 days before being asked to abstain from all oral hygiene measures for another 48 h prior to a second supervised brushing episode. Plaque was scored using a new modification of the Quigley & Hein Index (PI) at full mouth (FM), interproximal (IP) and smooth surfaces (SS). PIs were recorded before and after the supervised brushing episodes to enable the means of the within subject differences (pre- to post-brushing) to be compared between groups (ANOVA/t-tests). RESULTS: There were no significant differences in PI between groups at baseline or prior to the supervised brushings (p>0.05). Highly significant, mean reductions in PIs (approximately 1/2 of one PI unit) were observed for design B compared with the Sensiflex 2000 at FM and IP sites (p<0.0001) for both supervised brushing episodes. A significant reduction in PI at SS was seen only after the first brushing episode (p=0.0004). For design A, PI reductions were consistently greater than those for the Sensiflex 2000 but differences were only significant at the p<0.05 level. CONCLUSION: It is concluded that this model of clinical trial has sufficient power to demonstrate clinical superiority with respect to plaque removal for PTBs and can be used for testing one or more prototype designs of brush heads.

Adolescent↗

A clinical evaluation of a novel data logger to determine compliance with the use of powered toothbrushes.

OBJECTIVES: The primary objective of this study was to evaluate the viability of an electronic data logger to record the brushing episodes of patients receiving standardised oral hygiene instructions. The secondary objective was to estimate the compliance of a group of patients diagnosed with chronic periodontal disease with brushing time instructions for the daily use of a powered toothbrush over a 2-month period. MATERIAL AND METHODS: 17 modified Philips Jordan Sensiflex 2000 powered toothbrushes (PTBs) were provided to patients (32-67 years) attending for non-surgical management of chronic periodontal disease. The PTBs incorporated an electronic data logger which recorded, for each individual brushing event: the length of time the brush was used (identifying the brushing speed setting); the maximum, minimum and average current during operation; and the time spent charging in between two consecutive brushing events. The patients were given detailed instructions with the PTB and were told to use it for 2 min each morning and 2 min in the evening. The patients returned for non-surgical management over two visits prior to reinforcement of the oral hygiene instructions 1 month after PTB allocation. Subjects were asked to complete a simple brushing diary to record their use of the toothbrush on a daily basis. After 2 months of using the PTBs at home, the brushes and diaries were collected and the data downloaded from the data loggers. RESULTS: Of the 17 data loggers allocated, two recorded no information and two subjects did not return for the follow-up appointments. The data from the remaining 13 data loggers were evaluated for level of compliance. An event of brushing between 120 and 130 s was considered to be compliant, one of between 90 and 120 or 130-150 s was partially compliant and brushing for < 90 s or > 150 s was recorded as non-compliant. Percentage compliance for all the events (2087 recordings) was 34%, partial- and non-compliance were calculated as: 18%; 48% of events, respectively. CONCLUSION: This data logger has provided previously unrecorded data on the brushing times for a group of patients using a powered toothbrush at home during non-surgical management of chronic periodontal disease. The data suggested that almost half (48%) of the brushing events recorded by the data loggers were greater than 30 s above or below the instructed brushing time.

Adult↗

Efficacy of a prototype brush head for a powered toothbrush. A multicentre study.

PRIMARY OBJECTIVE: To evaluate a multicentre clinical trial design for testing powered toothbrushes. SECONDARY OBJECTIVE: To compare the efficacy of a prototype brush head (N2.3) for the Philips Jordan Sensiflex 2000 powered toothbrush (PTB) to that of Braun Oral-B D15 PTB in removing dental plaque MATERIAL AND METHODS: 137 volunteers (ages 18-25 years) were recruited to this 3-centre, 2-week, 2-group, 2-treatment, single-blind trial. Plaque was recorded at screening and again 14 days later at baseline. Stratification of subjects, for gender and screening PI, occurred at baseline. Subjects were then asked to abstain from all oral hygiene measures for 48 h followed by a supervised episode of brushing for 3 min with the allocated PTB. The allocated PTB was used at home for the next 12 days before a second abstinence from all oral hygiene measures for the 48 h prior to a second supervised brushing episode. Plaque levels were scored using a modification of the Quigley & Hein plaque index (PI) at full mouth (FM), interproximal (IP) and smooth surfaces (SS). To enable the means of the within subject differences (pre to postbrushing) to be compared between groups PIs were recorded before and after the supervised brushing episodes, differences between centres, groups and visits were examined. RESULTS: No significant differences in PI between groups at screening, baseline or prior to the supervised brushings were detected (P > 0.05 anova). The results of the analysis of variance showed there to be a highly significant difference (P < 0.001) between brushing groups, but, significant differences between centres (P < 0.001) and a significant interaction effect between centre and brushing group (P < 0.001) was also detected. Therefore the difference between groups was not present at all three centres. Further examination of the single centre data showed there to be greater levels of plaque removed by the N2.3 compared to the D15 (FM reduction in PI 1.95 vs. 1.13, respectively) at centre 3 in contrast to the other two centres where no difference was detected. The precise reason for these differences could not be established. CONCLUSIONS: A multicentre study design is applicable for evaluating PTBs but a minimum of 3 centres should be included so that differences between centres can be identified. The prototype brush head N2.3 for the Philips Jordan Sensiflex 2000 PTB has comparable plaque removal efficacy to the Braun Oral-B D15 PTB at FM, IP and SS sites.

Adolescent↗