Dataset Information

Examining the impact of oral hygiene advice and/or scale and polish on periodontal disease: the IQuaD cluster factorial randomised controlled trial.

ABSTRACT: Objective To compare the clinical effectiveness and cost benefit of different frequencies of scale and polish (S&P) treatments in combination with different types of oral hygiene advice (OHA).Design Multi-centre, multi-level cluster randomised factorial open trial with blinded outcome evaluation. UK dental practices were cluster randomised to deliver OHA as usual or personalised. In a separate randomisation, patients were allocated to receive S&P 6-monthly, 12-monthly or never.Setting UK primary dental care.Participants Practices providing NHS care and adults who had received regular dental check-ups.Main outcome measures The percent of sites with bleeding on probing, patient confidence in self-care, incremental net benefits (INB) over three years.Results Sixty-three practices and 1,877 adult patients were randomised and 1,327 analysed (clinical outcome). There was no statistically significant or clinically important difference in gingival bleeding between the three S&P groups (for example, six-monthly versus none: difference 0.87% sites, 95% CI: 1.6 to 3.3, p = 0.48) or between personalised or usual OHA groups (difference -2.5% sites, -95%CI: -8.3 to 3.3, p = 0.39), or oral hygiene self-efficacy (cognitive impact) between either group (for example, six-monthly versus none: difference -0.028, 95% CI -0.119 to 0.063, p = 0.543). The general population place a high value on, and are willing to pay for, S&P services. However, from a dental health perspective, none of the interventions were cost-effective.Conclusion Results suggest S&P treatments and delivering brief personalised OHA provide no clinical benefit and are therefore an inefficient approach to improving dental health (38% of sites were bleeding whatever intervention was received). However, the general population value both interventions.

SUBMITTER: Clarkson J

PROVIDER: S-EPMC7908958 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Examining the impact of oral hygiene advice and/or scale and polish on periodontal disease: the IQuaD cluster factorial randomised controlled trial.

Clarkson Jan J Ramsay Craig C Lamont Thomas T Goulao Beatriz B Worthington Helen H Heasman Peter P Norrie John J Boyers Dwayne D Duncan Anne A van der Pol Marjon M Young Linda L Macpherson Lorna L McCracken Giles G

British dental journal 20210226 4

Objective To compare the clinical effectiveness and cost benefit of different frequencies of scale and polish (S&P) treatments in combination with different types of oral hygiene advice (OHA).Design Multi-centre, multi-level cluster randomised factorial open trial with blinded outcome evaluation. UK dental practices were cluster randomised to deliver OHA as usual or personalised. In a separate randomisation, patients were allocated to receive S&P 6-monthly, 12-monthly or never.Setting UK primary ...[more]

PMID: 33637926

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Project description:Background40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI. Periodontal parameters, glycosylated haemoglobin (HbA1c) and high-sensitivity C-reactive protein (hs-CRP) were evaluated at baseline, 2- and 3-months intervals.Methods40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI. Periodontal parameters, glycosylated haemoglobin (HbA1c) and high-sensitivity C-reactive protein (hs-CRP) were evaluated at baseline, 2- and 3-months intervals.Results15 subjects from NSPT group and 17 from OHI group completed the study. The difference in plaque index (PI) between NSPT and OHI groups were significant at 2 months recall (p = 0.013). There was no significant difference between NSPT and OHI group for all other clinical periodontal parameters, HbA1c and CRP levels. At 3 months post-therapy, periodontal parameters improved significantly in both groups with sites with probing pocket depth (PPD) < 4 mm reported as 98 ± 1.8% in NSPT group and 92 ± 14.9% in OHI group. Mean PPD and mean probing attachment loss (PAL) within the NSPT group reduced significantly from baseline (2.56 ± 0.57 mm, 3.35 ± 0.83 mm) to final visit (1.94 ± 0.26 mm, 2.92 ± 0.72 mm) (p = 0.003, p < 0.001). For OHI group, improvements in mean PPD and mean PAL were also seen from baseline (2.29 ± 0.69 mm, 2.79 ± 0.96 mm) to final visit (2.09 ± 0.72 mm, 2.62 ± 0.97 mm) (p < 0.001 for both). Similarly, HbA1c levels decreased in both groups with NSPT group recording statistically significant reduction (p = 0.038). Participants who demonstrated ≥ 50% reduction in PPD showed significant reductions of HbA1c and hs-CRP levels (p = 0.004 and p = 0.012).ConclusionNSPT significantly reduced PI at 2 months post-therapy as compared to OHI. Both NSPT and OHI demonstrated improvements in other clinical parameters as well as HbA1c and CRP levels.Trial registrationClinicalTrials.gov: NCT01951547.

Project description:BackgroundDespite the implementation of the preschool oral healthcare programme (POHP) for 5-6-year-old children over the past 3 decades in Malaysia, dental plaque and caries levels in this age group remain high. Among the child-level attributable factors are unhealthy self-care behaviours (poor oral hygiene and high sugary diet). In order to improve the children's oral health, an improved programme called the 'Senyuman Indah Milik Semua' Programme (SIMSP) or 'Beautiful Smile for All' programme is introduced. In this programme, a triad of dental hygienist-teacher-parent works together to improve children's oral hygiene levels compared with the existing POHP that involves dental hygienists only. The aim of this study is to compare the effect of the SIMSP versus the existing POHP on oral hygiene levels of 5-6-year-old children in the Kampar district, Perak state, Malaysia.MethodsThis study is a pragmatic, cluster-randomised, parallel-group, matched pair, controlled trial with blinded outcome assessment. Randomisation is performed using a computer-generated table with a 1:1 allocation comparing the SIMSP and the POHP involving 28 preschools in the Kampar district, Perak, Malaysia. The intervention consists of preschool visits by a group of dental therapists, in-class oral health lessons and daily toothbrushing conducted by class teacher, child home toothbrushing supervised by parents, and infographic oral health messages to parents. The control consists of the existing POHP that involves preschool visits by a group of dental therapists only. The trial lasts for 6 months. Primary outcome variable is the mean plaque score change after 6 months. To determine the feasibility of the SIMSP, a process evaluation will be conducted using the perspectives of dental therapists, teachers, and parents on the appropriateness, effectiveness, facilitators, and barriers to the SIMSP implementation as well as an audit trail to assess the trial intervention.DiscussionCluster randomisation may lead to a random effect and cluster selection bias. These factors will be accounted for when analysing the data and interpreting the outcomes. The effectiveness of the SIMSP will be evaluated by comparing the results with those of the POHP.Trial registrationClinicalTrials.gov NCT04339647 . Registered on 5 April 2020 - Retrospectively registered.

Project description:BackgroundFew patients with lower bowel symptoms who consult their general practitioner need a specialist opinion. However data from referred patients suggest that those who are referred would benefit from detailed assessment before referral.MethodsA cluster randomised factorial trial. 44 general practices in North Trent, UK. Practices were offered either an electronic interactive referral pro forma, an educational outreach visit by a local colorectal surgeon, both or neither. The main outcome measure was the proportion of cases with severe diverticular disease, cancer or precancerous lesions and inflammatory bowel disease in those referred by each group. A secondary outcome was a referral letter quality score. Semi-structured interviews were conducted to identify key themes relating to the use of the softwareResultsFrom 150 invitations, 44 practices were recruited with a total list size of 265,707. There were 716 consecutive referrals recorded over a six-month period, for which a diagnosis was available for 514. In the combined software arms 14% (37/261) had significant pathology, compared with 19% (49/253) in the non-software arms, relative risk 0.73 (95% CI: 0.46 to 1.15). In the combined educational outreach arms 15% (38/258) had significant pathology compared with 19% (48/256) in the non-educational arms, relative risk 0.79 (95% CI: 0.50 to 1.24). Pro forma practices documented better assessment of patients at referral.ConclusionThere was a lack of evidence that either intervention increased the proportion of patients with organic pathology among those referred. The interactive software did improve the amount of information relayed in referral letters although we were unable to confirm if this made a significant difference to patients or their health care providers. The potential value of either intervention may have been diminished by their limited uptake within the context of a cluster randomised clinical trial. A number of lessons were learned in this trial of novel innovations.

Project description:BackgroundSharing trial results with participants is an ethical imperative but often does not happen. We tested an Enhanced Webpage versus a Basic Webpage, Mailed Printed Summary versus no Mailed Printed Summary, and Email List Invitation versus no Email List Invitation to see which approach resulted in the highest patient satisfaction with how the results were communicated.Methods and findingsWe carried out a cluster randomised, 2 by 2 by 2 factorial, nonblinded study within a trial, with semistructured qualitative interviews with some patients (ISRCTN96189403). Each cluster was a UK hospital participating in the ICON8 ovarian cancer trial. Interventions were shared with 384 ICON8 participants who were alive and considered well enough to be contacted, at 43 hospitals. Hospitals were allocated to share results with participants through one of the 8 intervention combinations based on random permutation within blocks of 8, stratified by number of participants. All interventions contained a written plain English summary of the results. The Enhanced Webpage also contained a short video. Both the Enhanced Webpage and Email contained links to further information and support. The Mailed Printed Summary was opt-out. Follow-up questionnaires were sent 1 month after patients had been offered the interventions. Patients' reported satisfaction was measured using a 5-point scale, analysed by ordinal logistic regression estimating main effects for all 3 interventions, with random effects for site, restricted to those who reported receiving the results and assuming no interaction. Data collection took place in 2018 to 2019. Questionnaires were sent to 275/384 randomly selected participants and returned by 180: 90/142 allocated Basic Webpage, 90/133 Enhanced Webpage; 91/141 no Mailed Printed Summary, 89/134 Mailed Printed Summary; 82/129 no Email List Invitation, 98/146 Email List Invitation. Only 3 patients opted out of receiving the Mailed Printed Summary; no patients signed up to the email list. Patients' satisfaction was greater at sites allocated the Mailed Printed Summary, where 65/81 (80%) were quite or very satisfied compared to sites with no Mailed Printed Summary 39/64 (61%), ordinal odds ratio (OR) = 3.15 (1.66 to 5.98, p < 0.001). We found no effect on patient satisfaction from the Enhanced Webpage, OR = 1.47 (0.78 to 2.76, p = 0.235) or Email List Invitation, OR = 1.38 (0.72 to 2.63, p = 0.327). Interviewees described the results as interesting, important, and disappointing (the ICON8 trial found no benefit). Finding out the results made some feel their trial participation had been more worthwhile. Regardless of allocated group, patients who received results generally reported that the information was easy to understand and find, were glad and did not regret finding out the results. The main limitation of our study is the 65% response rate.ConclusionsNearly all respondents wanted to know the results and were glad to receive them. Adding an opt-out Mailed Printed Summary alongside a webpage yielded the highest reported satisfaction. This study provides evidence on how to share results with other similar trial populations. Further research is needed to look at different results scenarios and patient populations.Trial registrationISRCTN: ISRCTN96189403.

Dataset Information

Examining the impact of oral hygiene advice and/or scale and polish on periodontal disease: the IQuaD cluster factorial randomised controlled trial.

Publications

Examining the impact of oral hygiene advice and/or scale and polish on periodontal disease: the IQuaD cluster factorial randomised controlled trial.

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