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An intraoral device for weight loss: initial clinical findings
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Design
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Qualitative Study
N= 7
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Objective
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To investigate the practicality, comfort, tolerability and safety of an intraoral device and also to determine the magnitude of weight loss achieved during a two-week study period
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Inclusion Criteria
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BMI>30, no major co-occurring health conditions, mouth free of periodontal disease and dental caries, with a sound posterior dentition with no missing teeth
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Exclusion Criteria
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Using continuous positive airway pressure devices to manage sleep apnea, diabetic patients on insulin and oral hypoglycemic therapy, Participants who were on oral medication that cannot be given in liquid form
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Methods
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Devices incorporating closed-field magnets with keepers to restrict the mouth from opening were implanted in seven participants. The intra-oral device was cemented to the participants' first molars.
The dental device was made up of stainless steel orthodontic-type metal bands fixed to the upper and lower posterior teeth by a combination of a glass-ionomer-based orthodontic cement. The device also had silicone-based cheek protectors to prevent friction. Lastly, a safety feature was incorporated to allow for disengagement of the device in the case of an emergency.
The patients were then given instructions on maintaining oral hygiene, mouthwash, and a commercially available liquid diet. The diet supplied 300 kcal of energy in a 200 ml bottle. The participants were prescribed 800 ml (1,200 kcal) per day in the form of four drinks, plus one protein shake (25 g of protein), and unrestricted low-calorie liquids such as tea and coffee.
The comfort and tolerability of the device were measured using a self-administered questionnaire. The quality of life (QoL) was measured using an impact of weight and QoL during review appointments at baseline, 1, 7 and 14 days, and 14 days post-device removal.
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Duration
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2-week study period
2-week follow-up
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Outcome Measures
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Weight change
Device tolerability
Quality of life of patients
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Baseline characteristics
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Of the participants, all seven patients were women and of European ethnicity.
Mean age: 36.71 y
Mean height: 162.5 cm (+5.59)
Mean weight: 107.98 kg (+23.22)
Mean BMI at baseline: 40.84 (+8.27)
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Results
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Weight change:
Of the seven participants who took part in the study, all lost weight, with a mean weight loss of 6.36 kg (SD = 3.79) of their body weight. However, two weeks following device removal, all the participants gained some weight, with an average weight gain of approximately 0.73 kg.
Mean weight loss of study participants at time points investigated:
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Time Period
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Mean Weight (kg)
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Baseline
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108
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24 hours
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106.8
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7 days
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104.5
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14 days
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101.6
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2 weeks after removal
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102.3
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Device Tolerability:
Values shown in mean (SD)
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Device tolerability
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Baseline
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24 hours
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7 days
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14 days
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2 weeks after removal
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Trouble pronouncing any words
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1.29 (0.488)
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2.86 (1.68)
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3.00 (1.633)
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3.00 (1.633)
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1.00 (0)
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Taste changes
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1.57 (0.98)
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1.43 (0.79)
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1.86 (0.69)
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1.86 (1.22)
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1.00 (0)
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Pain
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1.71 (0.95)
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3.43 (1.51)
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2.57 (1.51)
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3.14 (1.22)
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1.50 (0.55)
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Uncomfortable to drink
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1.43 (0.79)
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2.43 (1.51)
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1.71 (1.11)
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2.14 (1.46)
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1.00 (0)
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Self-conscious because of device
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1.71 (0.95)
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3.86 (1.22)
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3.29 (1.70)
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3.29 (1.70)
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1.00 (0)
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Felt tense
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1.86 (1.07)
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3.14 (1.47)
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2.86 (1.77)
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3.43 (1.99)
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1.00 (0)
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Oral hygiene is unsatisfactory
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1.57 (0.79)
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2.57 (1.40)
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3.14 (1.07)
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3.43 0.98)
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1.83 (0.99)
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Speech problem
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1.29 (0.488)
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3.43 (1.62)
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3.14 (1.78)
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3.14 (1.78)
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1.00 (0)
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Difficult to relax
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1.43 (0.787)
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3.57 (1.62)
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2.71 (1.60)
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3.14 (1.57)
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1.00 (0)
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Embarrassed
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1.86 (1.21)
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3.43 (1.6)
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2.71 (1.89)
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2.86 (1.77)
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1.00 (0)
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Been irritable
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1.71 (1.11)
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2.89 (1.57)
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2.14 (1.21)
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2.57 (1.51)
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1.00 (0)
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Difficulty doing your job
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1.43 (1.13)
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2.71 (1.60)
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2.43 (1.81)
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2.57 (1.51)
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1.00 (0)
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Life in general less satisfying
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1.86 (1.21)
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3.00 (1.73)
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3.00 (1.92)
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3.00 (1.73)
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1.00 (0)
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Totally unable to function
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1.29 (0.76)
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1.57 (1.13)
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1.57 (0.976)
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1.57 (0.787)
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1.00 (0)
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Quality of Life:
Values: mean (SD)
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Physical function
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Baseline
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14 days
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2 weeks after removal
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Because of my weight, I have trouble picking up objects
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4.000 (1.200)
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4.000 (1.000)
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4.500 (1.225)
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Because of my weight, I have trouble tying my shoes
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3.860 (1.200)
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4.290 (1.113)
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4.670 (0.816)
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Because of my weight, I have difficulty getting up from chairs
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3.860 (1.500)
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4.430 (1.134)
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4.500 (1.225)
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Because of my weight, I have trouble using stairs
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3.570 (1.300)
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4.140 (1.464)
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4.170 (1.602)
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Because of my weight, I have difficulty putting on or taking off my clothing
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4.140 (0.690)
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4.710 (0.488)
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4.830 (0.408)
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Because of my weight, I have trouble with mobility
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4.140 (1.100)
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4.290 (1.113)
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4.330 (1.211)
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Because of my weight, I have trouble crossing my legs
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3.390 (1.500)
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3.71 (1.380)
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3.670 (1.633)
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I feel short of breath with only mild exertion
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3.570 (1.300)
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3.570 (1.134)
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3.170 (1.329)
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I am troubled by painful or stiff joints
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3.570 (1.400)
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4.140 (0.690)
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3.670 (1.211)
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My ankles and lower legs are swollen at the end of the day
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2.430 (1.100)
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4.570 (0.787)
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4.330 (1.033)
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I am worried about my health
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2.430 (1.100)
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2.710 (0.951)
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2.000 (1.095)
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Study Author Conclusions
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Within the limitations of this study, it can be concluded that all the participants tolerated the device for two weeks and showed satisfactory weight loss.
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InpharmDTM Researcher
Critique
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While the obvious limitations such as small sample size and short follow-up period are present, the main concern lies in whether or not this technique can be applied in clinical practice. While there were positive results, this device caused social and physical discomfort, and many patients may not be open to this intervention.
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