The impact of combining dental interventions with dietary and exercise advice on waist circumference in patients with the metabolic syndrome: Protocol for a randomized controlled trial [post]

2019 unpublished
Metabolic Syndrome (MetS) associated with cardiovascular diseases have been focused on by researchers. Although various studies have investigated its relationship with the oral environment, the effects of dental interventions for MetS remain unclear. The aim of this trial is to investigate whether prosthetic or periodontal treatment combined with dietary and exercise advice can improve waist circumference, a surrogate measure of the syndrome. The null hypothesis is that there will be no
more » ... ce in waist circumference between participants who receive prosthetic or periodontal treatment combined with dietary and exercise advice and those who receive only dietary and exercise advice. Methods This is a single-center, single-blinded, parallel, randomized controlled trial. Participants are randomly allocated to an intervention group (dietary and exercise advice plus prosthetic or periodontal treatment) or a control group (dietary and exercise advice only). Outcome measures include waist circumference; blood pressure; serum triglyceride, serum HDL/LDL cholesterol, fasting blood glucose, and HbA1c assessment using blood tests; Anthropometric measurements using bioelectrical impedance; health-related quality of life assessment using MOS 36-Item Short-Form Health Survey; oral-health-related quality of life assessment using Oral Health Impact Profile-14 and Geriatric Oral Health Assessment Index; food and nutrient intake assessment using brief-type self-administered diet history questionnaire; periodontal assessment using probing pocket depth and bleeding on probing. Objective masticatory function assessment using a color-changeable chewing gum and a gummy jelly was conducted for the participants who received prosthetic treatment. Outcome measures are to be implemented at three time points: at baseline and at 1 and 3 months after intervention. Differences between two groups in each assessment is compared using the Student's t-test. Within group, the change between each assessment time is compared using the Tukey's test.
doi:10.21203/rs.2.479/v1 fatcat:7qqddkoy7bgbxk4r2xmqn46d2u