None listed
Conditions
Brief summary
This is an open-label uncontrolled intervention study of a 1200 calorie liquid diet plus an oral magnetic device which is attached to the back 4 teeth to prevent chewing. The aim is to test tolerability of the device and measure weight loss over two weeks in participants with a BMI >35, aged 20-65 with a healthy mouth and no major contraindication.
Interventions
A dental inspection will confirm each individual’s suitability for the study and baseline screening tests will be performed including medical history, dietary assessment, and measurement of weight and height. Separation elastics will be placed by a dental surgeon to allow for a reversible separation of the teeth. This appointment should take 30-45min. When adequate separation of the teeth is achieved after 2 weeks of continuous use of the elastics, a dental impression will be taken to allow for
A dental inspection will confirm each individual’s suitability for the study and baseline screening tests will be performed including medical history, dietary assessment, and measurement of weight and height. Separation elastics will be placed by a dental surgeon to allow for a reversible separation of the teeth. This appointment should take 30-45min. When adequate separation of the teeth is achieved after 2 weeks of continuous use of the elastics, a dental impression will be taken to allow for the manufacture of the dental device. This appointment should take 30-45min. The device is cemented to four of the patients’ upper and lower teeth by a dental surgeon and removed after a two week period. It consists of stainless steel orthodontic-type metal bands wrapped around four posterior teeth. A closed magnet and its keeper are attached to the upper and lower bands, which then restricts mouth opening. It is estimated that device fitting will take 1-2h per patient. A safety feature allows the disengagement of the device in case of an emergency (e.g. vomiting). Instead of eating solid food, the subjects will be given a liquid diet for 14 days. The 2-week low calorie diet (LCD) consists of 1200kcal/day (4 Fortisip bottles per day, plus some extra low-calorie liquids such as tea, coffee and diet lemonade). During this 2-week phase, participants will see a dietitian on a regular basis to discuss the acceptability of the liquid diet and fill out food diaries to monitor adherence to a low-calorie diet. This appointment should take 30-45min. During the study, participants will receive dental, dietetic and medical supervision before, during and after device placement. Subjects will be reviewed 24 hours and at 3, 7 and 14 days after the device has been placed and 2 weeks after the device removal. The comfort and tolerability of the device will be assessed, together with the resultant weight loss, at each time point. During the feasibility study, qualitative and quantitative data will be collected on: tolerance of the device, effect on oral health, weight loss, and acceptability to patients. These will be assessed using standard and modified Quality of Life (QoL) questionnaires. Data collected will inform further development and modification of the device, if needed.
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria include a BMI of over 35, no major co-occurring health conditions that may affect the ability of participating in the study, and a healthy mouth with a sound posterior dentition. Males and females aging 20-65 of all ethnicities will be invited to participate
Exclusion criteria
Participants using continuous positive airway pressure (CPAP) devices to manage sleep apnoea are not eligible. Any patient who is on oral medication that cannot be give in in liquid form; diabetic patients on insulin; and any patient with diabetes on oral hypoglycaemic therapy will be excluded from the study.
Outcome results
None listed